The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 80
Summary of PMA Originals Under Review
Total Under Review: 53
Total Active: 22
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 575
Total Active: 418
Total On Hold: 157
Summary of All PMA Submissions
Originals: 4
Supplements: 72
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 80
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 115.2
FDA Time: 97.1 Days
MFR Time: 18.1 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P120024
6/11/15
activL® Artificial Disc
Aesculap Implant Systems, LLC
Center Valley, PA 18034
Approval for the activL® Artificial Disc. This device is indicated for reconstruction of the disc at one level (L4-L5 or L5- S1) following single-level discectomy in skeletally mature patients with symptomatic degenerative disc disease (DDD) with no more than Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. The activL® Artificial Disc is implanted using an anterior retroperitoneal approach. Patients receiving the activL® Artificial Disc should have failed at least six months of nonoperative treatment prior to implantation of the device.
P140009
6/12/15
Brio Neurostimulation System
St. Jude Medical
Plano, TX,
75024
Approval for the Brio Neurostimulation System. This device is indicated for the following conditions: 1) Bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications; and 2) Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability.
P140021
6/11/15
Elecsys® Anti-HCV II Immunoassay and Elecsys® PreciControl Anti-HCV
Roche Diagnostics
Indianapolis, IN 46250
Approval for the Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV. This device is indicated for: Elecsys Anti-HCV II Immunoassay Immunoassay for the in vitro qualitative detection of antibodies to hepatitis C virus (HCV) in human adult and pediatric (ages 18 months through 21 years) serum and plasma (potassium EDTA, lithium heparin, sodium heparin, and sodium citrate). Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. The electroluminescence Immunoassay “ECLIA” is intended for use on the Roche cobas e 601 immunoassay analyzer. Elecsys PreciControl Anti-HCV Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCV immunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers and the Elecsys Anti-HCV II immunoassay on the cobas e 601 immunoassay analyzer.
P140025
6/12/15
VENTANA ALK (D5F3) CDx Assay
Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for the VENTANA ALK (D5F3) CDx Assay. This device is indicated for the following: VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib).
P140031
6/17/15
Edwards SAPIEN 3™ Transcatheter Heart Valve, model 9600TFX, 20, 23, 26, and 29 mm, and accessories (Edwards Commander™ delivery system, models 9600LDS20,
9600LDS23, 9600LDS26, and 9600LDS29, with crimp stopper and Qualcrimp crimping accessory; Edwards eSheath Introducer Set, models 914ES and 916ES; and
Edwards crimper, model 9600CR)
Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for the Edwards SAPIEN 3 Transcatheter Heart Valve, model 9600TFX, and accessories. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., Society of Thoracic Surgeons operative risk score ≥8% or at a ≥15% risk of mortality at 30 days).
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P820003/S134
6/4/15
Real-Time
Symbios IPG, Synergyst IPG
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P830055/S157
6/5/15
Real-Time
LCS® Total Knee System
Depuy Orthopaedics, Inc.
Warwaw, IN
465581
Approval for the addition of ATTUNE Cementless cruciate retaining (CR) and posterior stabilized (PS) Femoral components as compatible components with the approved ATTUNE CR and PS Rotating Platform (RP) Tibial Inserts and ATTUNE RP (cemented) Tibial Bases. Including sterile single use instrumentation, to be used with the approved ATTUNE RP components.
P830055/S159
6/25/15
Special
LCS® Total Knee System
Depuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for an additional inspection step.
P840001/S303
6/26/15
Special
Medtronic Spinal Cord Stimulation Systems
Medtronic Minneapolis, MN 55432
Approval for changes to the User Manual for the Implantable Neurostimulator Recharging Systems; specifically, the addition of a warning statement for the Antenna Locate feature, as well as instructions for exiting this feature, and directions to contact Medtronic if the patient encounters any problems.
P850048/S041
6/23/15
Real-Time
Access Hybritech PSA Reagents on the Access Immunoassay Systems
Beckman Coulter, Inc.
Chaska, MN
55318
Approval for labeling changes to align with Globally Harmonized System of Classification of chemicals (GHS) which provides a consistent hazard classification system that is recognized globally.
P850051/S083 6/4/15
Real-Time
Activitrax II IPG, Activitrax IPG, Legend IPG, Legend II IPG, Micro Minix IPG, Minix IPG, Minix ST IPG, Premier IPG, Prevail IPG, Vitatron Legacy SR IPG
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P860057/S135
6/11/15
Real-Time
Carpentier-Edwards PERIMOUNT Aortic & Mitral Bioprosthesis Families
Edwards Lifesciences, LLC.
Irvine, CA
92614
Approval for modification (elimination) to the centrail-Hole-in-air specification.
P890003/S330
6/4/15
Real-Time
CARELINK® MONITOR
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P900056/S145
6/19/15
Real-Time
Rotablator Rotational Atherectomy System
Boston Scientific
Maple Grove, MN 55311
Approval for a core wire vendor change and the associated rebranding of the RotaWire Guidewire as the RotaWire Elite Guidewire.
P900061/S134
6/4/15
Real-Time
Application Software, Medtronic GEM ICD, Medtronic Jewel ICD, Medtronic Jewel Plus ICD, Medtronic Micro Jewel ICD, Medtronic PCD Tachyarrhythmia Control System
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P920015/S152
6/4/15
Real-Time
Medtronic PCD Tachyarrhythmia Control System
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P920048/S009
6/24/15
Real-Time
Rapid fFN For the TLiIQ System
Hologic, Inc.
Sunnyvale, CA 94089
Approval for the use of a new resin in the plasma fibronectin (pFN) affinity column used to purify the A120 fetal fibronectin specific antibody contained in the Rapid fFN test for the TLiIQ System. Additionally, the implementation of a modified arginine containing neutralization buffer to decrease precipitation of the A120 antibody from the buffer.
P930022/S018 6/4/15
Real-Time
Legend Plus IPG
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P930038/S074
6/16/15
135-Day
Angio-Seal Vascular Closure Device
St. Jude Medical, Inc.
Plymouth, MN 55442
Approval for change to the inspection method for package temperature indicators.
P930039/S130
6/22/15
180-Day
CapSureFix Novus MRI SureScan Lead
Medtronic, Inc.
Mounds View, MN 55112
Approval for the use of the CapSureFix Novus MRI SureScan Lead Model 5076 MRI with the Advisa SR MRI A3SR01 Implantable Pulse Generator.
P950037/S150
6/19/15
180-Day
Dromos Drisk Rate Adaptive pacing System
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the QP CRT-D device models with one IS4 port, one IS-1 port and one DF4 port along with a updated software – PSW 1502.U for the devices.
P960009/S169
6/22/15
180-Day
Implantable Multi-programmable Quadripolar Deep Brain Stimulation System
Medtronic Inc.
Minneapolis, MN 55432
Approval for a labeling update that modifies the Deep Brain Stimulation (DBS) Therapy Information for Prescriber’s and the DBS Patient Therapy Guide. The labeling update is to modify two precautions that appear in each manual: 1) Remove the precaution on potential release of neurotoxic and carcinogenic compounds from polyurethane lead materials; and 2) Modify the precaution on long-term safety of multiple leads and replacement leads to read: The long-term safety associated with implanting more than one lead on the same side of the brain is unknown.
P960009/S230
6/26/15
Special
Medtronic Deep Brain Stimulation Systems
Medtronic Minneapolis, MN 55432
Approval for changes to the User Manual for the Implantable Neurostimulator Recharging Systems; specifically, the addition of a warning statement for the Antenna Locate feature, as well as instructions for exiting this feature, and directions to contact Medtronic if the patient encounters any problems.
P970003/S174
6/4/15
180-Day
VNS Therapy System
Cyberonics, Inc.
Houston, TX
77058
Approval of the post-approval study protocol.
P970004/S187
6/26/15
180-Day
Medtronic InterStim Therapy for Urinary Control
Medtronic Inc.
Minneapolis, MN 55432
Approval for the Model 3579 Cable and Model 3676 Cable and associated changes to enable use of the approved Verify™ Evaluation System with the approved temporary test stimulation leads.
P970012/S097 6/4/15
Real-Time
Kappa 400 IPG
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P970018/S031
6/15/15
180-Day
BD PrepStain System
BD Diagnostics
Sparks, MD
21152
Approval for a manufacturing site located Sparks, MD.
P970038/S030
6/9/15
135-Day
Access Hybritech Free PSA Reagent Assay
Beckman Coulter, Inc.
Chaska, MN
55318
Approval for a change to the process for purifying GtxBiotin polyclonal antibody from goat antiserum.
P970038/S031
6/23/15
Real-Time
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems
Beckman Coulter, Inc.
Chaska, MN
55318
Approval for labeling changes to align with Globally Harmonized System of Classification of chemicals (GHS) which provides a consistent hazard classification system that is recognized globally.
P970051/S126
6/15/15
180-Day
CochlearTM Nucleus® Cochlear Implant System
Cochlear Americas
Centennial, CO 80111
Approval for the CI522 cochlear implant.
P970051/S129
6/23/15
Real-Time
Nucleus® Cochlear™ Implant System
Cochlear Americas
Centennial, CO 80111
Approval for design changes to the CP900 Series Processor Coil which makes the CP900 Series Processor compatible with the N22 implant and allows recipients of the N22 Implant access to the newest processor technology.
P980016/S537 6/4/15
Real-Time
Evera S ICD, Evera XT ICD, GEM ICD, GEM II ICD, GEM III ICD, Intrinsic ICD, Intrinsic 30 ICD, Marquis ICD, Maximo ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, RVLIA, Secura ICD, Virtuoso II ICD and Application Software
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P980035/S421 6/4/15
Real-Time
Adapta IPG, Versa IPG, Sensia IPG, Advisa IPG, Advisa MRI IPG, Application Software, AT500 DDDRP Pacing System IPG, EnPulse E1 IPG, EnPulse E2 IPG, Kappa IPG, Relia IPG
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P980035/S424
6/22/15
180-Day
Advisa SR MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval for the use of the CapSureFix Novus MRI SureScan Lead Model 5076 MRI with the Advisa SR MRI A3SR01 Implantable Pulse Generator.
P980041/S032
6/23/15
Real-Time
Access AFP Reagents on the Access Immunoassay Systems
Beckman Coulter, Inc.
Chaska, MN
55318
Approval for labeling changes to align with Globally Harmonized System of Classification of chemicals (GHS) which provides a consistent hazard classification system that is recognized globally.
P980050/S099 6/4/15
Real-Time
Jewel AF ICD and Application Software
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P990001/S120
6/4/15
Real-Time
ProVit Software, Vitatron C20 IPG, Vitatron C60 IPG, Vitatron T20 IPG, Vitatron T60 IPG, and Application Software
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P000009/S062
6/19/15
180-Day
Phylax AV ICD System
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the QP CRT-D device models with one IS4 port, one IS-1 port and one DF4 port along with a updated software – PSW 1502.U for the devices.
P000037/S041
6/19/15
180-Day
On-X Prosthetic Heart Valve
On-X Technologies, Inc.
Austin, TX
78752
Approval of the post-approval study protocol.
P010013/S063
6/15/15
180-Day
NovaSure Impedance Controlled Endometrial Ablation System
Hologic, Inc.
Marlborough, MA 01752
Approval of the following changes to the post-approval study for the device: To increase in number of study sites.
P010015/S271 6/4/15
Real-Time
Application Software, Consulta CRT-P, InSync IPG, Syncra CRT-P, Viva CRT-P
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P010031/S500 6/4/15
Real-Time
Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Right Ventricular Lead Integrity Alert (RVLIA), Concerto II CRT-D, Consulta CRT-D, Insync ICD, Insync II Protecta ICD, Insync III Marquis ICD, Insync Maximo ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D and Application Software
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P010047/S034
6/17/15
Real-Time
Progel™ Pleural Air Leak Sealant
Neomend, Inc.
Irvine, CA
92618
Approval for modifying the storage conditions of Progel™ Pleural Air leak. The inclusion of a consecutive or cumulative controlled room temperature storage excursion of 8 °C to 25 °C for a period up to 35 days within the approved 24-month shelf life when the device is normally stored between 2 °C to 8°C.
P020002/S010
6/2/15
180-Day
ThinPrep Imaging System
Hologic, Inc.
Marlborough, MA 01752
Approval for use of the ThinPrep Imaging System with the slides prepared by the ThinPrep 5000 slide processor.
P020014/S041
6/29/15
180-Day
Essure System
Bayer Healthcare LLC
Milpitas, CA
95035
Approval for changing the Essure Instructions for Use to replace the previously approved modified hysterosalpin-gogram confirmation test with the transvaginal ultrasound/ hysterosalpin-gogram confirmation test algorithm.
P020014/S043
6/9/15
180-Day
Essure System
Bayer HealthCare, LLC
Whippany, NJ 07981
Approval for a manufacturing site located at Bayer Healthcare SRL in Heredia, Costa Rica.
P020025/S074
6/23/15
Special
IntellaTip MiFi XP Temperature Ablation Catheters
Boston Scientific Corporation
San Jose, CA
95134
Approval for clarifications to the electrical connection sequence in the Directions For Use (DFU).
P020050/S021
6/2/15
Real-Time
WaveLight® EX500 Excimer Laser System – Excimer Laser System, WaveNet™ Planning Software (WPS) – Standalone Software, ALLEGRO Topolyzer VARIO – Topographer
Alcon Laboratories, Inc.
Lake Forest, CA 92630
Approval for a new software release for the WaveLight® EX500 Excimer Laser System (Model 1016-3), WaveNet™ Planning Software (WPS) – Standalone Software. (Model 6164), and ALLEGRO Topolyzer VARIO – Topographer (Model 1028) The devices, as modified, will continue to be marketed under the trade names WaveLight® EX500 Excimer Laser System – Excimer Laser System (Model 1016-3), WaveNet™ Planning Software (WPS) – Standalone Software. (Model 6164), and ALLEGRO Topolyzer VARIO – Topographer (Model 1028).
P020056/S031
6/3/15
180-Day
Natrelle Silicone-filled Breast Implants
Allergan Incorporated
Goleta, CA
93117
Approval for a line extension identified as the Natrelle Inspira Silicone-Filled Breast Implants to add breast implant options to the Natrelle Silicone-filled Breast Implants.
P030002/S034
6/2/15
180-Day
Trulign Toric Posterior Chamber Intraocular Lens
Bausch & Lomb, Inc.
Aliso Viejo, CA 92656
Approval of the post-approval study protocol.
P030008/S019
6/2/15
Real-Time
WaveLight® EX500 Excimer Laser System – Excimer Laser System, WaveNet™ Planning Software (WPS) – Standalone Software, ALLEGRO Topolyzer VARIO
Alcon Laboratories, Inc.
Lake Forest, CA 92630
Approval for a new software release for the WaveLight® EX500 Excimer Laser System (Model 1016-3), WaveNet™ Planning Software (WPS) – Standalone Software. (Model 6164), and ALLEGRO Topolyzer VARIO – Topographer (Model 1028) The devices, as modified, will continue to be marketed under the trade names WaveLight® EX500 Excimer Laser System – Excimer Laser System (Model 1016-3), WaveNet™ Planning Software (WPS) – Standalone Software. (Model 6164), and ALLEGRO Topolyzer VARIO – Topographer (Model 1028).
P040002/S054
6/17/15
Special
AFX Endovascular AAA System
Endologix, Inc.
Irvine, CA
92618
Approval for updates to the AFX Instructions for Use to clarify existing information related to procedure planning and follow-up imaging, and to improve the instructions for delivery system withdrawal of the AFX Vela Proximal Endograft.
P050023/S085
6/19/15
180-Day
Inventra 7 HF-T QP CRT-D, Iperia 7 HF-T QP CRT-D, Itrevia 7 HF-T QP CRT-D, Iperia 5 HF-T QP CRT-D, Itrevia 5 HF-T QP CRT-D
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the QP CRT-D device models with one IS4 port, one IS-1 port and one DF4 port along with a updated software – PSW 1502.U for the devices.
P050052/S049
6/4/15
Panel-Track
Radiesse® Injectable Implant
Merz North America
Franksville, WI 53126
Approval for the Radiesse® Injectable Implant. The device is indicated for hand augmentation to correct volume loss in the dorsum of the hands
P060040/S041
6/3/15
Real-Time
Thoratec Heartmate II LVAS
Thoratec Corp.
Pleasanton, CA 94588
Approval for the Unshielded 14V Power Module Patient Cable.
P080006/S081
6/29/15
180-Day
Attain Ability Straight Left Ventricular Lead
Medtronic, Inc.
Mounds View, MN 55112
Approval to the post-approval study to close enrollment of the Model 4396 PAS upon completion of the interim analysis, which will be included within the 54 month progress report.
P070008/S062
6/19/15
180-Day
Stratos LV CRT-P, Stratos LV-T CRT-P, Corox OTW BP Lead, Corox OTW-S BP Lead
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the QP CRT-D device models with one IS4 port, one IS-1 port and one DF4 port along with a updated software – PSW 1502.U for the devices.
P080025/S083
6/26/15
180-Day
Medtronic InterStim Therapy for Bowel Control
Medtronic Inc.
Minneapolis, MN 55432
Approval for the Model 3579 Cable and Model 3676 Cable and associated changes to enable use of the approved Verify™ Evaluation System with the approved temporary test stimulation leads.
P090013/S184
6/4/15
Real-Time
Application Software, Revo MRI IPG
Medtronic, Inc.
Mounds View, MN
55112
Approval for an upgrade to the Bomgar Server and addition of redundant remote control blocker software.
P090018/S029
6/19/15
Real-Time
Esteem® System
Envoy Medical Corporation
St. Paul, MN
55110
Approval for a change to the UV epoxy material in the header connector of the sound processor and for a new plasma pre-treatment step to enhance adhesion of the silicone dip coating.
P090026/S015
6/23/15
Real-Time
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems
Beckman Coulter, Inc.
Chaska, MN
55318
Approval for labeling changes to align with Globally Harmonized System of Classification of chemicals (GHS) which provides a consistent hazard classification system that is recognized globally.
P100022/S013
6/8/15
180-Day
LAPBAND™ Adjustable Gastric Banding
Apollo Endosurgery, Inc.
Austin, TX
78746
Approval for a post-approval study protocol.
P100026/S033
6/30/15
180-Day
Neuropace RNS System
Neuropace, Inc.
Mountain View, CA 94043
Approval for a post-approval study protocol.
P100026/S034
6/30/15
180-Day
Neuropace RNS System
Neuropace, Inc.
Mountain View, CA 94043
Approval for a post-approval study protocol.
P100042/S004
6/5/15
180-Day
Aptima HPV Assay
Hologic, Inc.
San Diego, CA 92121
Approval for a post approval study labeling update. The device, as modified, will be marketed under the trade name Aptima HPV Assay. The Aptima HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The Aptima HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the Aptima HPV Assay. The assay is used with the Tigris DTS System or the Panther System. The use of the test is indicated: 1) To screen women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy; and 2) In women 30 years and older, the Aptima HPV Assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. * Broom-type device (e.g., Wallach Pipette) or endocervical brush/spatula.
P100047/S045
6/29/15
180-Day
Heartware Ventricular Assist System
HeartWare, Inc.
Miami Lakes, FL 33014
Approval of the post-approval study protocol.
P100047/S053
6/9/15
180-Day
HeartWare® Ventricular Assist System
HeartWare, Inc.
Miami Lakes, FL 33014
Approval for alternate battery cells and updated software for the HeartWare Ventricular Assist Device (HVAD) Battery pack.
P110002/S012
6/30/15
Special
Mobi-C® Cervical Disc Prosthesis (One-Level)
LDR Spine USA, Incorporated
Austin, TX
78750
Approval for clarifications in the Surgical Technique Manual.
P110009/S012
6/30/14
Special
Mobi-C® Cervical Disc Prosthesis (Two-Leve
LDR Spine USA, Incorporated
Austin, TX
78750
Approval for clarifications in the Surgical Technique Manual.
P110010/S096
6/1/15
Panel Track
PROMUS Element™ Plus and Promus PREMIER™ Everolimus- Eluting Platinum Chromium Coronary Stent Systems (Monorail™ and Over-the-Wire)
Boston Scientific Corp.
Maple Grove, MN
55311
Approval for the PROMUS Element Plus and Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent Systems (Monorail and Over-the-Wire). These devices are indicated for improving luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length.
P110010/S105
6/2/15
Real-Time
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System-OTW
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a design change to the stent delivery system manifold.
P110023/S015
6/24/15
135-Day
EverFlex Self-Expanding Peripheral Stent System
ev3 Endovascular, Inc.
Plymouth, MN 55441
Approval for alternate stent laser cutting equipment.
P110024/S001
6/15/15
Real-Time
ResQCPR System
Advanced Circulatory Systems, Inc.
Roseville, MN 55113
Approval for a modification to the timing light switch extension on the ResQPOD ITD 16.
P120007/S003
6/5/15
180-Day
Aptima HPV 16 18/45 Genotyping Assay
Hologic, Inc.
San Diego, CA 92121
Approval for a post approval study labeling update. The device, as modified, will be marketed under the trade name Aptima HPV 16 18/45 Genotype Assay. The Aptima HPV 16 18/45 Genotype Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with Aptima HPV Assay positive results. The Aptima HPV 16 18/45 Genotype Assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the Aptima HPV 16 18/45 Genotype Assay. The assay is used with the Tigris DTS System or the Panther System. The use of the test is indicated: 1) In women 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, the Aptima HPV 16 18/45 Genotype Assay can be used to test samples from women with Aptima HPV Assay positive results to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy; and 2) In women 30 years and older, the Aptima HPV 16 18/45 Genotype Assay can be used to test samples from women with Aptima HPV Assay positive results. The assay results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45. This information, together with the physician’s assessment of cytology history, other risk factors, and professional guidelines, may be used to guide patient management. * Broom-type device (e.g., Wallach Pipette), or endocervical brush/spatula.
P120010/S058
6/9/15
135-Day
MiniMed 530G System
Medtronic Minimed
Northridge, CA 91325
Approval for a change in the pre-dosing process of the Enlite sensor adhesive patch. The Enlite sensor (MMT-7008) is a component of the MiniMed 530G System.
P130005/S008
6/25/15
Real-Time
Diamondback 360 Coronary Orbital Atherectomy System (OAS)
Cardiovascular Systems, Inc.
St. Paul, MN
55112
Approval to change the black colorant used in the on/off button of the Diamondback 360 Coronary Orbital Atherectomy Device.
P130005/S009
6/25/15
Real-Time
Diamondback 360 Coronary Orbital Atherectomy System (OAS)
Cardiovascular Systems, Inc.
St. Paul, MN
55112
Approval for an update to the seal on components of the Orbital Atherectomy Device (OAD).
P130007/S002
6/22/15
Real-Time
Animas Vibe System
Animas Corp.
West Chester, PA 19380
Approval for substitution of 4 components (memory, transistor, micro-processing unit, connector) on the Printed Circuit Board (PCB) of the approved Animas Vibe Insulin Pump. One of the replacement components (micro-processing unit) requires a modification to the PCB layout.
P130009/S001
6/2/15
180-Day
Maestro® Rechargeable System
EnteroMedics, Inc.
Saint Paul, MN 55113
Approval of the post-approval study protocol.
P130021/S014
6/22/15
180-Day
Medtronic CoreValve™ Evolut™ R System
Medtronic CoreValve LLC
Santa Rosa, CA 95403
Approval for a design iteration of the 23, 26, and 29 mm Medtronic CoreValve™ System. The new components include CoreValve™ Evolut™ R Transcatheter Aortic Valves, models EVOLUTR-23-US, EVOLUTR-26-US, and EVOLUTR-29-US, EnVeo™ R Delivery Catheter System, Model ENVEOR-US, and EnVeo™ R Loading Systems, Models LS-ENVEOR-23US and LS-ENVEOR-2629US. These components will be marketed under the trade name CoreValve™ Evolut™ R System.
P130024/S002
6/30/15
180-Day
Lutonix 035 Drug Coated Balloon PTA Catheter
Lutonix, Inc.
New Hope, MN 5542
Approval for the 120 mm and 150 mm device sizes.
P140003/S002
6/17/15
Special
Impella 2.5 System
Abiomed, Inc.
Danvers, MA
01923
Approval for the implementation of additional quality control measurements for fluid tightness of the Impella Purge Cassette.
P140010/S002
6/19/15
180-Day
IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Medtronic, Inc.
Santa Rosa, CA 95403
Approval of the post-approval study protocol.
P140010/S003
6/19/15
180-Day
IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
Medtronic, Inc.
Santa Rosa, CA 95403
Approval of the post-approval study protocol.
P140010/S006
6/24/15
Real-Time
IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter
Medtronic Vascular, Inc.
Santa Rosa, CA 95403
Approval for an extension of the shelf life of the product from 12 to 24 months.
30-Day Notices (135 Day Supplement was not required)
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
N12159/S034
6/4/15
Surgicel Family of Absorbable Hemostats
Ethicon Incorporated
Somerville, NJ 08876
Expansion of the Clean Manufacturing Environment (CME) area at the Ethicon, LLC – San Lorenzo manufacturing facility.
P830063/S007
6/26/15
Prismaflex TPE 2000 Set
Baxter Healthcare Corporation
Round Lake, IL
60073
Change to the pyrogen test method (from rabbit test to kinetic-chromogenic LAL test) used for product release of Prismaflex TPE 2000 sets.
P840001/S301
6/8/15
Restore, ltrel, and Synergy Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Leads
Medtronic Neuromodulation
Minneapolis, MN 55432
Transfer of incoming inspection activities.
P840001/S302
6/11/15
Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems and Pisces, Specify, and Vectris SCS Leads
Medtronic Neuromodulation
Minneapolis, MN 55432
Update the final functional testing software.
P840064/S060
6/2/15
PROVISC® Ophthalmic Viscosurgical Device (OVD)
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Replace the currently used assay and identification techniques with an alternate method which will identify and assay sodium hyaluronate in the PROVISC® and DUOVISC® Ophthalmic Viscosurgical Devices (OVD).
P860004/S228
6/26/15
SynchroMed Infusion System
Medtronic Neuromodulation
Minneapolis, MN 55432
RSW Interface Controller Software Program for use during manufacturing of the Synchromed II Pump (Model 8637).
P860004/S229
6/26/15
SynchroMed Infusion System
Medtronic Neuromodulation
Minneapolis, MN 55432
Addition of in-process monitoring for catheter tubing inner diameter plasma treatment.
P860057/S137
6/18/15
Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Pericardial Mitral Bioprosthesis
Edwards Lifesciences, LLC.
Irvine, California 92614
Add a packaging line and increase the maximum personnel capacity of the Changi, Singapore clean room #4 from 285 to 402 personnel.
P870072/S060
6/4/15
Thoratec Ventricular Assist Device System
Thoratec Corp.
Pleasanton, CA
94588
Implementation of a supplier’s facility relocation for certain components of the Thoratec Heartmate II Ventricular Assist System and Thoratec Ventricular Assist Device System.
P890047/S046
6/2/15
DUOVISC® Ophthalmic Viscosurgical Device (OVD)
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Replace the currently used assay and identification techniques with an alternate method which will identify and assay sodium hyaluronate in the PROVISC® and DUOVISC® Ophthalmic Viscosurgical Devices (OVD).
P890047/S047
6/2/15
DUOVISC® Ophthalmic Viscosurgical Device (OVD)
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Replace the currently used assay and identification techniques with an alternate method which will identify and assay sodium hyaluronate in the PROVISC® and DUOVISC® Ophthalmic Viscosurgical Devices (OVD).
P900033/S048
6/25/15
Integra Dermal Regeneration Template
Integra LifeSciences Corporation
Plainsboro, NJ 08536
Qualification of a new method for Quarterly Sterilization Dose Audits for the Integra Dermal Regeneration Template manufactured at the Plainsboro, New Jersey, Integra manufacturing facility.
P900056/S147
6/12/15
Rotoblator Rotational Angioplasty System
Boston Scientific Corporation
Maple Grove, MN 55311
Manufacturing process change of the RotaLink Advancer and Catheter manufacturing lines.
P930038/S076
6/4/15
Angio-Seal Vascular Closure Device
St. Jude Medical, Inc.
Plymouth, MN 55442
Reduction in the lower shipment temperature limit for Angio-Seal product transportation to and from the sterilizer.
P930039/S131
6/6/15
CapSureFix Novus Lead, CapSureFix Novus Lead and CapSureFix Novus MRI SureScan Lead, Vitatron Crystalline Active Fixation Lead, Vitatron Crystalline Active Fixation Lead
Medtronic, Inc.
Mounds View, MN 55112
Updates to the equipment and process for plasma-treated tubing.
P930039/S132
6/16/15
CapSureFix Lead
Medtronic, Inc.
Mounds View, MN 55112
Change the supplier of the Sleeve Head component.
P940016/S017
6/15/15
Heparin-Induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Futura Apheresis System
B. Braun Medical Inc.
Allentown, PA 18109
Proposed reduction of controls performed at the end of each batch.
P940016/S018
6/16/15
Heparin-Induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Futura Apheresis System
B. Braun Medical Inc.
Allentown, PA 18109
Reduction in testing amount for Aluminum determination during in-process controls.
P940016/S019
6/18/15
Heparin-Induced Extracorporeal Lipoprotein Precipitation
B. Braun Medical Inc.
Allentown, PA 18109
Implementation of an additional drying step during the production process.
P950005/S057
6/2/15
EZ Steer DS Celsius Catheter Interface Cable
Biosense Webster, Inc.
Diamond Bar, CA 91765
Acceptance of a supplier manufacturing site change for vacuum-formed plastic tray components.
P950037/S154
6/12/15
Evia DR, Evia DR-T, Evia SR, Evia SR-T, Entovis DR, Entovis DR-T, Entovis SR, Entovis SR-T, Estella DR, Estella DR-T, Estella SR, Estella SR-T, Effecta D, Effecta DR, Effecta S, Effecta SR, Ecuro DR, Ecuro DR-T, Ecuro SR, Ecuro SR-T Pulse Generators
Biotronik, Inc.
Lake Oswego, OR 97035
Change to the spring bushings used in the device header and the associated manufacturing equipment.
P950037/S155
6/22/15
Entovis, Evia, Estella, Effecta, Ecuro, Eluna 8, Etrinsa 8, and Epyra 8 Implantable Pulse Generators; Selox, Setrox, TILDA, Dextrus, Safio, and Solox Pacemaker Leads
Biotronik, Inc.
Lake Oswego, OR 97035
Update the bioburden test method for routine monitoring of sterilized devices.
P960004/S069
6/29/15
FINELINE™ II Sterox Endocardial Pacing Leads
Boston Scientific Corporation
Saint Paul, MN 55112
Change to the internal inspection requirements for moisture content of the two part medical adhesive.
P960009/S228
6/11/15
Activa Deep Brain Stimulation Therapy System
Medtronic Neuromodulation
Minneapolis, MN 55432
Update the final functional testing software.
P960040/S346
6/4/15
ORIGEN ™ EL ICD, ORIGEN™ MINI ICD, DYNAGEN™ EL ICD, DYNAGEN™ MINI ICD, INOGEN™ EL ICD, INOGEN™ MINI ICD, INCEPTA™ ICD, ENERGEN™ ICD, PUNCTUA™ ICD
Boston Scientific Corporation
St. Paul, MN
55112
Enhance the IS-1 and IS-4 coil spring inspections at the supplier by adding an automated vision (AVI) system.
P960040/S347
6/22/15
DYNAGEN™, INOGEN™, ORIGEN™, PUNCTUA™, ENERGEN™, INCEPTA™ ICD’s and CRT-D’s
Boston Scientific Corporation
St. Paul, MN
55112
Remove a process monitoring step during battery anode manufacturing for the devices.
N970012/S109
6/24/15
AMS 700 Inflatable Penile Prosthesis
American Medical Systems, Inc.
Minnetonka, MN 55343
Qualification of the Laser Fixture Method as a replacement for the current caliper method used for measuring a critical tube dimension.
P980016/S539
6/29/15
P980016/S539 Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Update to the hybrid tracking during manufacturing for the devices.
P980023/S067
6/12/15
Linox Smart SD Leads, Linox Smart TD Leads, Linox Smart Leads, Volta 1CR Leads,Volta 1CT Lead, Volta 2 CR Leads, Volta 2 CT Leads, Protego SD Leads, Protego TD Leads, Protego S Leads, Protego Lead
Biotronik, Inc.
Lake Oswego, OR 97035
Use of alternate laser equipment for the manufacture of ICD Leads.
P980023/S068
6/22/15
Linoxsmart, Volta, Protego, and Kainox VCS Defibrillation Leads
Biotronik, Inc.
Lake Oswego, OR 97035
Update the bioburden test method for routine monitoring of sterilized devices.
P980035/S425
6/16/15
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Reduction in the weld monitoring frequency for selected weld manufacturing operations for the battery used in the devices.
P980035/S426
6/29/15
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI
Medtronic, Inc.
Mounds View, MN 55112
Update to the hybrid tracking during manufacturing for the devices.
P980035/S427
6/27/15
Advisa SR MRI
Medtronic, Inc.
Mounds View, MN 5511
Four (4) manufacturing changes for the Advisa SR MRI Model A3SR01 that had been previously approved for predecessor devices to align the Advisa SR MRI manufacturing process with the predecessor device manufacturing processes: 1) IC Supplier Process Flow update to BiCMOS; 1) Additional Leak Test Station for Medium Rate Battery; 2) Additional Work Stations at Medium Rate Battery Supplier; and 3) Final Pack Equipment Implementation (CoquilPuls Line) – Phase II.
P990025/S046
6/2/15
EZ Steer Nav, NavStart Catheter Interface Cable
Biosense Webster, Inc.
Diamond Bar, CA 91765
Acceptance of a supplier manufacturing site change for vacuum-formed plastic tray components.
P990071/S031
6/16/15
SMARTABLATE SYSTEM
Biosense Webster, Inc.
Diamond Bar, CA 91765
Change to the assembler of the Printed Circuit Board Modules (PCB Modules) that are used in the Stockert 70 RF generator.
P000053/S060
6/24/15
AMS 800 Urinary Control System
American Medical Systems, Inc.
Minnetonka, MN 55343
Qualification of the Laser Fixture Method as a replacement for the current caliper method used for measuring a critical tube dimension.
P010001/S012
6/11/15
Transcend Hip Articulation System
CeramTec Gmbh
Plochingen,
Germany
73207
Addition of a grinding machine.
P010012/S388
6/4/15
DYNAGEN™ CRT-D, DYNAGEN™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D, INCEPTA™ ICD, ENERGEN TM ICD, PUNCTUA™ ICD, ESSENTIO PG, PROPONENT PG, PROPONENT PG, ACCOLADE PG, ALTRUA PG, VALITUDE CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Enhancement of the IS-1 and IS-4 coil spring inspections at the supplier by adding an automated vision (AVI) system.
P010012/S389
6/22/15
DYNAGEN™, INOGEN™, ORIGEN™, PUNCTUA™, ENERGEN™, INCEPTA™ ICD’s and CRT-D’s
Boston Scientific Corporation
St. Paul, MN
55112
Remove a process monitoring step during battery anode manufacturing for the devices.
P010012/S390
6/29/15
EASYTRAK 2 Coronary Venous Steroid Eluting Bipolar Pace/Sense Leads, EASYTRAK 3 Coronary Venous Steroid Eluting Bipolar Pace/Sense Leads ACUITY Spiral Lead
Boston Scientific Corporation
Saint Paul, MN 55112
Change to the internal inspection requirements for moisture content of the two part medical adhesive.
P010015/S273
6/16/15
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Reduction in the weld monitoring frequency for selected weld manufacturing operations for the battery used in the devices.
P010015/S274
6/29/15
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Update to the hybrid tracking during manufacturing for the devices.
P010020/S033
6/24/15
AMS Acticon Neosphincter Artificial Bowel Sphincter
American Medical Systems, Inc.
Minnetonka, MN 55343
Qualification of the Laser Fixture Method as a replacement for the current caliper method used for measuring a critical tube dimension.
P010022/S388
6/4/15
DYNAGEN™ CRT-D DYNAGEN™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D, ORIGEN™ CRT-D, ORIGEN™ X4 CRT-D, INCEPTA™ ICD, ENERGEN™ ICD, PUNCTUA™ ICD, ESSENTIO PG, PROPONENT PG, PROPONENT PG, ACCOLADE PG, ACCOLADE PG, ALTRUA PG, VALITUDE CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Enhance the IS-1 and IS-4 coil spring inspections at the supplier by adding an automated vision (AVI) system.
P010030/S062
6/30/15
LifeVest 4000 Wearable Defibrillator
Zoll Manufacturing Corporation
Pittsburgh, PA 15238
Make the ‘Monitor Detect and Treat’ test permanent; Automate the Monitor Detect and Treat test; Replace the existing AutoTest monitor pulse test with the automated monitor detect and treat test in a subsequent step of the production process.
P010031/S502
6/29/15
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRTD, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Update to the hybrid tracking during manufacturing for the devices.
P010047/S039
6/26/15
Progel® Pleural Air Leak Sealant
Neomend, Inc.
Irvine, CA
92618
Add a second supplier for the bioburden testing, which is performed on a quarterly basis to confirm bioburden levels prior to release of the Extended Applicator Spray Tips for ethylene oxide sterilization remain acceptable.
P010068/S047
6/2/15
EZ Steer Nav DS Catheter Interface Cable
Biosense Webster, Inc.
Diamond Bar, CA 91765
Acceptance of a supplier manufacturing site change for vacuum-formed plastic tray components.
P020004/S116
6/11/15
GORE EXCLUDER AAA Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Implement a change in the test method used for receiving acceptance activities for raw materials.
P020025/S072
6/12/15
Intellatip Mifi Xp Temperature Ablation Catheter
Boston Scientific
San Jose, CA
95134
Change in the distance of measure in the mini electrode and several minor adjustments to the laser micrometer.
P030009/S081
6/12/15
Integrity Coronary Stent Systems
Medtronic, Inc.
Galway, Ireland
Alternative manufacturing line for a component of the MicroTrac Delivery Catheter.
P030017/S227
6/11/15
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems
Boston Scientific Corporation
Neuromodulation
Valencia, CA
91355
Addition of a tray sealing machine.
P030017/S228
6/26/15
Precision® and Precision Spectra™ Spinal Cord Stimulator (SCS) Systems
Boston Scientific Corporation
Neuromodulation
Valencia, CA
91355
Addition for alternate test equipment system used for the testing of the Printed Circuit Board Assembly (PCBA) of the charger.
P030031/S068
6/2/15
Celsius ThermoCool Electrophysiology Catheter ThermoCool SF Uni-Directional Catheter
Biosense Webster, Inc.
Diamond Bar, CA 91765
Acceptance of a supplier manufacturing site change for vacuum-formed plastic tray components.
P040027/S043
6/3/15
Gore VIATORR TIPS Endoprosthesis
W.L. Gore & Associates, Inc
Phoenix, AZ
85085
Use of an alternate powder to coat the stent frame.
P040027/S044
6/11/15
GORE VIATORR TIPS Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Implement a change in the test method used for receiving acceptance activities for raw materials.
P040037/S079
6/2/15
Gore Viabahn Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Change in the heat treatment manufacturing procedure, the use of a new container closure system, as well as the addition of two suppliers for a processing aid.
P040037/S080
6/11/15
GORE VIABAHN Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Implement a change in the test method used for receiving acceptance activities for raw materials.
P040043/S074
6/11/15
GORE TAG Thoracic Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Implement a change in the test method used for receiving acceptance activities for raw materials.
P050006/S047
6/11/15
GORE HELEX Septal Occluder & GORE Cardioform Septal Occluder
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Implement a change in the test method used for receiving acceptance activities for raw materials.
P050023/S091
6/12/15
Ilesto 7 HF-T, Ilesto 5 HF-T, Iforia 7 HF-T, Iforia 5 HF-T, Inventra 7 HF-T (DF-1), Inventra 7 HF-T (DF4), Iperia 7 HF-T (DF-1), Iperia 7 HF-T (DF4), Iperia 5 HF-T (DF-1), Iperia 5 HF-T (DF4), Itrevia 7 HF-T (DF-1), Itrevia 7 HF-T (DF4), Itrevia 5 HF-T (DF-1), Itrevia 5 HF-T (DF4) CRT-Ds
Biotronik, Inc.
Lake Oswego, OR 97035
Change to the spring bushings used in the device header and the associated manufacturing equipment.
P050023/S092
6/22/15
Iperia 7, Itrevia 7, Inventra 7, Illesto 7, Iforia 7, and Lumax 740 ICDs and CRT-Ds; Protego Defibrillation Leads
Biotronik, Inc.
Lake Oswego, OR 97035
Update the bioburden test method for routine monitoring of sterilized devices.
P050038/S024
6/24/15
ARISTA AH Absorbable Hemostat
Davol, Inc
Woburn, MA
01801
Qualification of an additional pouch sealer.
P050046/S025
6/29/15
ACUITY Steerable Lead System
Boston Scientific Corporation
Saint Paul, MN 55112
Change to the internal inspection requirements for moisture content of the two part medical adhesive.
P050052/S066
6/3/15
Radiesse(+) Dermal Filler
Merz North America, Inc.
Franksville, WI 53126
Increase of the maximum batch size using existing equipment, and implementation of a new mixing blade operated at a lower speed.
P960009/S227
6/8/15
Activa Deep Brain Stimulation Therapy System
Medtronic Neuromodulation
Minneapolis, MN 55432
Transfer of incoming inspection activities, for a number of device components used in the manufacture of Neuromodulation leads, extensions and accessories from the Medtronic Rice Creek manufacturing facility to Medtronic Puerto Rico Operation Cneters (MPROC) in Villalba and Juncos.
P060040/S042
6/4/15
Thoratec Heartmate II Ventricular Assist System
Thoratec Corp.
Pleasanton, CA
94588
Implementation of a supplier’s facility relocation for certain components of the Thoratec Heartmate II Ventricular Assist System and Thoratec Ventricular Assist Device System.
P070008/S065
6/12/15
Evia HF, Evia HF-T, Entovis HF, Entovis HF-T CRT-Ps
Biotronik, Inc.
Lake Oswego, OR 97035
Change to the spring bushings used in the device header and the associated manufacturing equipment.
P070008/S066
6/22/15
Eluna 8, Etrinsa 8, Epyra 8, Evia, and Stratos CRT-Ps; Corox OTW and CELERITY Left Ventricular Pacing Leads
Biotronik, Inc.
Lake Oswego, OR 97035
Update the bioburden test method for routine monitoring of sterilized devices.
P080006/S082
6/25/15
Attain Ability Lead
Medtronic Incorporated
Mounds View, MN 55112
Minor modifications to manufacturin