The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130.3 Days
MFR Time: 98.7 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P140008
8/5/15
Orbera™ Intragastric Balloon
Apollo Endosurgery, Inc.
Austin, TX
78746
Approval for the Orbera Intragastric Balloon. The ORBERA™ Intragastric Balloon System is indicated for use as an adjunct to weight reduction for adults with obesity with Body Mass Index (BMI) of ≥ 30 and ≤ 40 kg/m2 and is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of significant long-term weight loss and maintenance of that weight loss. ORBERA™ is indicated for adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. The maximum placement period for ORBERA™ is 6 months.
P150010
8/28/15
HYMOVIS
Fidia Farmaceutici, S.p.A.
Brookline, MA 02446
Approval for HYMOVIS. This device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen).
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P810031/S054
8/25/15
180-Day
Healon5® Ophthalmic Viscosurgical Device
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Approval to update the labeling for the Healon5® Ophthalmic Viscosurgical Device (OVD) to remove the physician training program for new users and to revise the precautions section of the directions for use to allow for other OVD removal techniques.
P820003/S135
8/17/15
Real-Time
Pasys, Pasys ST, Spectrax S, Spectrax SX, Spectrax SX-HT, Spectrax SXT, Symbios, Synergyst
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P850051/S084
8/17/15
Real-Time
Activitrax, Activitrax II, Legend, Legend II, Micro Minix, Minix, Minix ST, Premier, Prevail, Vitatron Legacy SR
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P880006/S093
8/27/15
180-Day
Sensolog / Dialog / Regency family of pacemakers
St. Jude Medical, Inc.
Sunnyvale, CA 94085
Approval for the new Endurity Core family of pacemakers, the Merlin 20.1.1 PCS Programmer Software which supports the new device models, updated MerlinConduct 1.3 Mobile Application Software, and support for the Merlin Electronic Health Record DirectExport feature.
P880086/S255
8/27/15
180-Day
Affinity / Integrity / Victory / Zephyr / Accent family of pacemakers
St. Jude Medical, Inc.
Sunnyvale, CA 94085
Approval for the new Endurity Core family of pacemakers, the Merlin 20.1.1 PCS Programmer Software which supports the new device models, updated MerlinConduct 1.3 Mobile Application Software, and support for the Merlin Electronic Health Record DirectExport feature.
P890003/S333
8/17/15
Real-Time
Elite, Elite II, Minuet, Preva, Preva D, Prodigy, Synergyst II, Thera, Thera-i, Analyzer, Vitatron Legacy, Vitatron Legacy II, Reveal Insertable Loop Recorder Software, Reveal LINQ
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P900033/S047
8/6/15
Real-Time
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template
Integra Lifesciences Corporation
Plainsboro, NJ 08536
Approval for adding two new size offerings: 4cm x 4cm and 7cm x 7cm.
P900061/S136
8/17/15
Real-Time
Gem, Jewel, Micro Jewel, Jewel Plus, Micro Jewel II, PCD
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P910023/S355
8/27/15
180-Day
Ellipse/Fortify Assura family of ICDs
St. Jude Medical, Inc.
Sunnyvale, CA 94085
Approval for the new Endurity Core family of pacemakers, the Merlin 20.1.1 PCS Programmer Software which supports the new device models, updated MerlinConduct 1.3 Mobile Application Software, and support for the Merlin Electronic Health Record DirectExport feature.
P920015/S159
8/17/15
Real-Time
PCD, Sprint Quattro Lead, Transvene Lead
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P930021/S014
8/26/15
180-Day
STRAUMANN® EMDOGAIN™
STRAUMANN USA, LLC
Andover, MA 01810
Approval for adding the use of biphasic calcium phosphate (HAIJ3-TCP) bone graft materials with Straumann Emdogain, adding the use of collagen and other graft materials with Straumann Emdogain and changing the name of a contract manufacturer, in name only, from Sverige, Scan AB to HKScan Sweden AB. The device, as modified, will be marketed under the trade name STRAUMANN EMDOGAIN and is indicated for use as an adjunct to periodontal surgery as a topical application onto exposed root surfaces. Emdogain is indicated for the treatment of the following conditions: 1) Intrabony defects due to moderate or severe periodontitis; 2) Mandibular degree II furcations with minimal interproximal bone loss; 3) Gingival recession defects in conjunction with surgical coverage procedures such as the coronally advanced flap technique; and 4) Emdogain is also indicated for use in a minimally invasive surgical technique in esthetic zones to optimize tissue height for intrabony defects only. In cases of wide defects or where soft tissue support is desired, Straumann Emdogain can be used in conjunction with a bone graft material. For further information on the use of Emdogain with bone graft materials, please refer to, For Straumann Emdogain in Conjunction with Bone Graft Material in Wide Defects in the Clinical Procedure Section of the draft instructions.
P930022/S019
8/17/15
Real-Time
Legend Plus
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P930031/S054
8/12/15
Real-Time
Wallstent TIPS Endoprosthesis
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a change in device labeling from MR Safe to MR Conditional.
P940016/S016
8/11/15
180-Day
Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
B. Braun Medical, Inc.
Allentown, PA 18109
Approval for the H.E.L.P. Optimized Therapy (HOT) configuration.
P960013/S061
8/13/15
180-Day
Tendril, Tendril ST, Tendril STS, and Optisense leads
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for MCRD and steroid coating test methodologies, specifications, stability protocols and other manufacturing processes to meet the requirements in the agreed upon steroid commitment letter.
P960016/S055
8/31/15
180-Day
Livewire TC Steerable Electrophysiology Catheter
St. Jude Medical
St. Paul, MN
55117
Approval of a process and design change for the shaft of the Livewire TC Ablation Catheter.
P960030/S031
8/13/15
180-Day
Passive Plus, Isoflex S & P, and Isoflex Optim leads
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for MCRD and steroid coating test methodologies, specifications, stability protocols and other manufacturing processes to meet the requirements in the agreed upon steroid commitment letter.
P960058/S114
8/14/15
180-Day
HiResolution Bionic Ear System
Advanced Bionics
Valencia, CA
91355
Approval for expanding the Naída CI Sound Processor Family, which are external components of the HiResolution Bionic Ear system, by adding two new sound processors (CI Q90 and CI Q30), new versions of the PowerCel battery, and a new version of the SoundWave Professional Suite fitting software.
P970003/S179
8/21/15
Real-Time
Pulse Generator, Pulse Duo Generator
Cyberonics, Inc.
Houston, TX
77058
Approval for the introduction of an alternate microprocessor, manufactured by a different vendor, for the Model 102/102R Pulse Generators used in the VNS Therapy System.
P970008/S064
8/28/15
Real-Time
Urologix Targis® System for the Treatment of BPH
Urologix, Inc.
Minneapolis, MN 5544
Approval for modifications to the design and manufacturing procedures of the patient cable.
N970012/S110
8/4/15
Special
AMS 700™ Series Penile Prosthesis Product Line
AMS Ambicor™ Penile Prosthesis
American Medical Systems, Inc.
Minnetonka, MN
55343
Approval for modification of the Instructions for Use to expand the Adverse Device Effects information to reflect newly acquired information.
P970012/S098
8/17/15
Real-Time
Kappa 400
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P970013/S064
8/27/15
180-Day
Microny family of pacemakers
St. Jude Medical, Inc.
Sunnyvale, CA 94085
Approval for the new Endurity Core family of pacemakers, the Merlin 20.1.1 PCS Programmer Software which supports the new device models, updated MerlinConduct 1.3 Mobile Application Software, and support for the Merlin Electronic Health Record DirectExport feature.
P980016/S541
8/17/15
Real-Time
EnTrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Protecta DF4, Protecta, Protecta XT DF4, Protecta XT, Secura DF4, Secura, Virtuoso, Virtuoso II, Evera S DR, Right Ventricular Lead Integrity Alert, Evera S VR, Evera XT DR, Evera XT VR
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P980022/S176
8/25/15
180-Day
Paradigm Real-Time Continuous Glucose Monitoring System,
Paradigm Real-Time Revel Continuous Glucose Monitoring System .
Medtronic Minimed
Northridge, CA 91325
Approval for design and manufacturing changes to the DSCap and case bottom to include a metric thread interface for the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Insulin Pumps (model numbers MMT-522, 522k, 523, 523k, 722, 722k, 723, 723k), and MiniMed 530G Insulin Pumps (model numbers MMT-551, 751), which are components of the Paradigm Real-Time and Paradigm Real-Time Revel Continuous Glucose Monitoring System, and theMinimed 530g system.
P980033/S043
8/12/15
Real-Time
Wallstent Venous Endoprosthesis
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a change in device labeling from MR Safe to MR Conditional.
P980035/S431
8/17/15
Real-Time
Adapta, Advisa, AT500, EnPulse, EnRhythm, Kappa 600, Kappa 650, Kappa 700, Kappa 800, Kappa 900, Relia, Sensia, Sigma, Versa
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P980040/S062
8/25/15
180-Day
Tecnis Toric 1-Piece Intraocular Lens (IOL)
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Approval of the post-approval study protocol.
P980050/S101
8/17/15
Real-Time
Jewel AF, GEM III AT
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P990001/S121
8/17/15
Real-Time
Diamond II, Ruby II, Topaz II, Jade II, Vita DDDR, Vita DDD, Vita VVIR, Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita II DDDR, Vita II, Selection AFm, C-Series, T-Series
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P990009/S040
8/21/15
180-Day
Floseal Hemostatic Matrix
Baxter Healthcare Corporation.
Round Lake, IL 60073
Approval for a manufacturing site located at Baxter Healthcare Corporation,in Cleveland, Mississippi.
P000039/S050
8/14/15
180-Day
AMPLATZER Septal Defect Occluder
St. Jude Medical Inc.
Plymouth, MN 55442
Approval for manufacturing sites located at St. Jude Medical, Cost Rica Ltda.
P010015/S275
8/17/15
Real-Time
Consulta CRT-P, InSync, InSync III, Syncra CRT-P, Viva CRT-P
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P010031/S505
8/17/15
Real-Time
Concerto, Right Ventricular Lead Integrity Alert, Concerto II CRT-D, Consulta CRT-D, InSync ICD, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II CRT-D, Maximo II DF4, Protecta CRT-D, Protecta DF4, Protecta XT CRT-D, Protexta XT DF4, Brava CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P020012/S011
8/7/15
180-Day
Bellafill PMMA Collagen Dermal Filler
Suneva Medical, Inc.
Alexandria, VA
22314
Approval for a change in product labeling that described the results of your 5-year Post-Approval Study (P521-01).
P020025/S075
8/19/15
Real-Time
Intellatip Mifi Xp Temperature Ablation Catheter
Boston Scientific
San Jose, CA
95134
Approval for a minor design change to the proximal shaft of your Intellatip MiFi XP Temperature Ablation Catheter.
P020056/S023
8/3/15
180-Day
Natrelle Silicone-Filled Breast Implants
Allergan
Santa Barbara, CA
93111
Approval for the redesign of the post approval study protocol.
P030035/S133
8/27/15
180-Day
Frontier / Frontier II / Anthem family of CRT-Ps
St. Jude Medical, Inc.
Sunnyvale, CA 94085
Approval for the new Endurity Core family of pacemakers, the Merlin 20.1.1 PCS Programmer Software which supports the new device models, updated MerlinConduct 1.3 Mobile Application Software, and support for the Merlin Electronic Health Record DirectExport feature.
P030054/S150
8/13/15
180-Day
QuickSite, QuickFlex, and QuickFlex μ leads
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for MCRD and steroid coating test methodologies, specifications, stability protocols and other manufacturing processes to meet the requirements in the agreed upon steroid commitment letter.
P030054/S284
8/27/15
180-Day
Quadra Assura / Unify Assura family of CRT-Ds
St. Jude Medical, Inc.
Sunnyvale, CA 94085
Approval for the new Endurity Core family of pacemakers, the Merlin 20.1.1 PCS Programmer Software which supports the new device models, updated MerlinConduct 1.3 Mobile Application Software, and support for the Merlin Electronic Health Record DirectExport feature.
P040003/S015
8/31/15
180-Day
ExAblate Magnetic Resonance Guided Focused Ultrasound System
Insightec
Dallas, TX
75244
Approval for changes to the indications for use statement, physician labeling, and patient labeling. The device, as modified, will be marketed under the trade name ExAblate Magnetic Resonance Guided Focused Ultrasound System and is indicated to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure and whose uterine size is less than 24 weeks.
P040013/S021
8/21/15
180-Day
GEM 21S Growth-Factor Enhanced Matrix
Luitpold Pharmaceuticals, Inc.
Valley Forge, PA 19403
Approval of the post-approval study protocol.
P040016/S134
8/12/15
135-Day
VeriFLEX (Liberté) Bare-Metal Coronary Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for removal of the stent mass in-process measurement and an alternate sampling plan for the wall thickness in-process measurement.
P040033/S028
8/10/15
Special
Birmingham Hip Resurfacing (BHR) System
Smith & Nephew Orthopaedics
Cordova, TN
38016
Approval for modifications to the device labeling.
P040044/S059
8/3/15
Real-Time
MynxGrip Vascular Closure Device
Access Closure, Inc.
Santa Clara, CA
95054
Approval for a new coextruded balloon subassembly of the MynxGrip Vascular Closure Device.
P040046/S012
8/3/15
180-Day
Natrelle 410 Highly Cohesive Silicone-Filled Breast Implants
Access Closure, Inc.
Santa Clara, CA
95054
Approval for the redesign of the post approval study protocol.
P040046/S013
8/5/15
180-Day
Natrelle 410 Highly Cohesive Silicone-Filled Breast Implants
Allergan, Inc.
Irvine, CA
92612
Approval for twenty-eight (28) additional Natrelle 410 devices that include: Four (4) sizes of Style FL 410; Four (4) sizes of Style ML 410; One (1) size of Style LM 410; Three (3) sizes of Style LL 410; Two (2) sizes of Style LF 410; Four (4) sizes of Style FX 410; Four (4) sizes of Style MX 410; and Six (6) sizes of Style LX 410. These twenty-eight (28) additional Natrelle 410 devices encompass a range of: Volume = 140-775 cc; Width = 9.5-15.5 cm; Height = 7.6-16.0 cm; and Projection = 2.9-7.1 cm.
P050017/S011
8/13/15
Special
Zilver Vascular Stent
Cook Medical Incorporated
Bloomington, IN 47402
Approval for the addition of a tactile inspection step during incoming quality control.
P050037/S061
8/5/15
Special
Radiesse, Radiesse (+)
Merz North America, Inc.
Franksville, WI
53126
Approval for changes in Product Labeling including: warning and precautions related to potential rare but serious adverse events associated with the intravascular injection of soft tissue filler in the face including temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis and damage to underlying facial structures.
P050052/S071
8/5/15
Special
Radiesse, Radiesse (+)
Merz North America, Inc.
Franksville, WI
53126
Approval for changes in Product Labeling including: warning and precautions related to potential rare but serious adverse events associated with the intravascular injection of soft tissue filler in the face including temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis and damage to underlying facial structures.
P060006/S064
8/12/15
135-Day
Express SD Renal Monorail Premounted System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for removal of the stent mass in-process measurement and an alternate sampling plan for the wall thickness in-process measurement.
P080020/S014
8/3/15
180-Day
Gel-One®
Seikagaku Corporation
Rockville, MD
20852
Approval for revisions to the Package Insert and the Patient Information for Gel-One® as follows: 1) Revision of the statement, The safety and effectiveness of a repeat treatment cycle of Gel-One® have not been established. To the statement, The effectiveness of repeat treatment cycles of Gel-One® has not been established; and 2) Citation of clinical study data for retreatment with Gel-One® in support of the revision of this statement as described above.
P080030/S013
8/7/15
180-Day
iStent Trabecular Micro-Bypass Stent System
Glaukos Corporation
Laguna Hills, CA 92653
Approval to update your labeling to include the results of your Post-Approval Study (PAS) for the iStent Trabecular Micro-Bypass Stent System, Extended Follow-up of the Investigational Device Exemption (IDE) Cohort Study.
P090003/S037
8/12/15
135-Day
Express LD Iliac Premounted System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for removal of the stent mass in-process measurement and an alternate sampling plan for the wall thickness in-process measurement.
P090013/S193
8/17/15
Real-Time
Revo MRI, EnRhythm MRI
Medtronic Inc.
Mounds View, MN 55112
Approval for an update to the 2090 CareLink Programmer Desktop Software Model 9986.
P090016/S009
8/6/15
Real-Time
Belotero Balance
Merz North America, Inc.
Franksville, WI
53126
Approval of the post approval study protocol.
P090016/S016
8/6/15
Real-Time
Belotero Balance
Merz North America, Inc.
Franksville, WI
53126
Approval for addition of needle artwork and instructions for needle attachment to the Instructions for Use in the package insert.
P100022/S015
8/13/15
Special
Zilver PTX Drug Eluting Peripheral Stent
Cook Medical Incorporated
Bloomington, IN 47402
Approval for the addition of a tactile inspection step during incoming quality control.
P100046/S003
8/26/15
180-Day
AtriCure® Synergy Ablation System
Atricure Inc.
West Chester, OH 45069
Approval for a design change that includes replacement of the current isolator and electrode sub-assemblies with an over molded configuration.
P110008/S003
8/5/15
180-Day
Coflex® Interlaminar Technology
Paradigm Spine, LLC
New York, NY 10022
Approval of the post-approval study protocol.
P110027/S008
8/6/15
180-Day
therascreen® KRAS RGQ PCR Kit
QIAGEN Manchester, Ltd.
Manchester, UK
M15 6SH
Approval for the change in manufacturing of a critical reagent (Taq polymerase) and the conversion of a manual reagent fill process to one that is automated.
P120005/S033
8/19/15
180-Day
Dexcom G5 Mobile Continuous Glucose Monitoring System
Dexcom, Inc.
San Diego, CA 92121
Approval for changes to the Dexcom transmitter and receiver and the addition of the Dexcom G5 Mobile App, to enable the transmission of CGM data to the receiver and/or compatible Apple mobile devices, and to allow entry of system calibration information directly from compatible Apple mobile devices. The device, as modified, will be marketed under the trade name Dexcom G5 Mobile Continuous Glucose Monitoring System and is indicated as follows: The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 and older) with diabetes. The system is intended for single patient use and requires a prescription. The Dexcom G5 Mobile System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Dexcom G5 Mobile System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G5 Mobile System results should be based on the trends and patterns seen with several sequential readings over time.
P120010/S052
8/25/15
180-Day
Minimed 530g System
Medtronic Minimed
Northridge, CA 91325
Approval for design and manufacturing changes to the DSCap and case bottom to include a metric thread interface for the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Insulin Pumps (model numbers MMT-522, 522k, 523, 523k, 722, 722k, 723, 723k), and MiniMed 530G Insulin Pumps (model numbers MMT-551, 751), which are components of the Paradigm Real-Time and Paradigm Real-Time Revel Continuous Glucose Monitoring System, and theMinimed 530g system.
P120022/S010
8/6/15
180-Day
therascreen® EGFR RGQ PCR Kit
QIAGEN Manchester, Ltd.
Manchester, UK
M15 6SH
Approval for the change in manufacturing of a critical reagent (Taq polymerase) and the conversion of a manual reagent fill process to one that is automated.
P130008/S008
8/24/15
Real-Time
Inspire Upper Airway Stimulation Therapy
Inspire Medical Systems, Inc.
Maple Grove, MN 55369
Approval for extension of the shelf life of the Model 3024 Implantable Pulse Generator (IPG) to 3 years.
P130017/S002
8/18/15
Real-Time
Cologuard™
Exact Sciences Corporation
Madison, WI
53719
Approval to extend the shelf life of the Cologuard assay reagents (Cologuard Molecular Assay Reagents, Cologuard Molecular Controls, Cologuard Hemoglobin Assay Reagents, and Cologuard Hemoglobin Controls), on the basis of additional real-time stability testing, from a shelf-life of six (6) months to a shelf-life of nine (9) months.
P130017/S003
8/19/15
Real-Time
Cologuard™
Exact Sciences Corporation
Madison, WI
53719
Approval for several minor modifications to the Test Definition Software for Cologuard™.
P130021/S013
8/3/15
180-Day
Core Valve System
Medtronic, Inc.
Santa Rosa, CA 95403
Approval for the revised plunger assembly for the AccuTrak Delivery Catheter System (DCS).
P130026/S006
8/20/15
Real-Time
Tacticath Quartz Set
St. Jude Medical
Plymouth, MN 55442
Approval to modify how the proximal end of the pullwire is attached to the catheter’s handle.
P140026/S001
8/3/15
180-Day
ENROUTE™ Transcarotid Stent System
Silk Road Medical, Inc.
Sunnyvale, CA
94085
Approval of the post approval study protocol.
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
N16895/S097
8/19/15
Soflens® (polymacon) Visibility Tinted Contact Lens
Bausch & Lomb Incorporated
Rochester, NY 14609
Use of a more purified form of the raw material and implementation for a tightened raw material purity specification.
P840001/S309
8/20/15
Restore, Itrel, And Synergy Spinal Cord Stimulation System And Pisces, Resume, Specify, And Vectris Spinal Cord Stimulation Leads
Medtronic Inc.
Minneapolis, MN 55432
Changes to the final functional testing (FFT) software of the implantable neurostimulators at Medtronic Puerto Rico Operations in Juncos, Puerto Rico.
P850007/S034
8/26/15
Physio-Stim® and Spinal-Stim®
Orthofix
Lewisville, TX 75056
Implementation of an alternate machine to produce transducer coils (Cervical-Stim only) and remove redundant inspection of various device components.
P860004/S234
8/18/15
SynchroMed Infusion System
Medtronic Inc.
Minneapolis, MN 55432
Change for a re-design to the manufacturing fixture used to place the hybrid and battery in the SynchroMed II Infusion Pump.
P860057/S138
8/7/15
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral
Bioprostheses
Edwards Lifesciences, LLC
Irvine, CA
92614
Extend the shelf life of the polytetrafluoroethylene sewing thread from 5 years to 10 years.
P900056/S150
8/20/15
Rotablator Rotational Atherectomy System
Boston Scientific Corporation
Maple Grove, MN
55311
Adding an alternate component material supplier.
P900060/S054
8/31/15
Carbomedics Prosthetic Heart Valve
Sorin Group Canada, Inc.
Burnaby, BC Canada
V5J 5M1
Upgrade the Leaflet Proof Tester.
P910007/S049
8/13/15
ARCHITECT Total PSA
Abbott Laboratories
Abbott Park, IL 60064
Replace the polypropylene resin used in the manufacture of ARCHITECT Reaction Vessels.
P910071/S015
8/28/15
ADATO® SIL-OL 5000 Silicone Oil
Bausch & Lomb Incorporated
Irvine, CA
92618
Addition of a reinforcing head seam to the inner pouch of the device.
P930014/S083
8/26/15
AcrySof® Intraocular Lenses (IOLs)
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Change to a new measurement system for quality control inspection of optical performance of your AcrySof® monofocal IOLs (P930014) (Models SN60WF, SN6CWS, SA60WF, SA60AT, SN60AT, Type 7B, MA30AC, MN60AC, MA60AC, US60MP, MN60MA, and MA60MA).
P930039/S136
8/18/15
CapSureFix Lead 5568; CapSureFix Lead 5067
Medtronic, Inc.
Mounds View, MN 55112
Outsource three components from Medtronic Energy and Component Center (MECC) to an alternate supplier for the devices.
P950005/S058
8/18/15
Celsius FLTR Uni-Directional Ablation Catheter
Biosense Webster, Inc.
Diamond Bar, CA 91765
Acceptance of a new production machine for performing reflow of the quad lumen tip.
P950037/S158
8/31/15
Setrox, Dextrus, Safio, Tilda ICD’s
Biotronik, Inc.
Lake Oswego, OR 97035
Alternate supplier for the iridium coating process on the leads.
P960004/S072
8/18/15
Fineline II Pacing Leads
Boston Scientific Corporation
St. Paul, MN
55112
Remove circular tools from use in the manufacturing of FINELINE II pacing leads.
P960009/S235
8/13/15
Activa DBS Therapy System
Medtronic Neuromodulation
Minneapolis, MN 55432
Implementation of a new automated inspection procedure for use in the DBS lead distal-end straightness inspection procedure; the Automated Inspection System is intended to replace the manual inspection procedure.
P960009/S236
8/10/15
Activa Deep Brain Stimulation Therapy System
Medtronic Inc.
Minneapolis, MN 55432
Changes to the final functional testing (FFT) software of the implantable neurostimulators at Medtronic Puerto Rico Operations in Juncos, Puerto Rico.
P960040/S352
8/8/15
INCEPTA™ ICDs, PUNCTUA™ ICDs, DYNAGEN™ ICDs, INOGEN™ ICDs, ORIGEN™ ICDs
Boston Scientific
St. Paul, MN
55112
Add an additional inspection step to pulse generator case half manufacturing, along with associated specification and inspection criteria, that will allow pulse generator case half discontinuities to be distinguished from dents.
P960040/S353
8/21/15
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
Saint Paul, MN 55112
Addition of an alternate semi-automated ‘thickness and loading’ process step to the battery manufacturing line.
N970003/S181
8/8/15
Essentio Pacemaker, Proponent Pacemaker, Accolade Pacemaker, Altrua 2 Pacemaker
Boston Scientific CRM
St. Paul, MN
55112
Add an automated vision inspection system for the coil spring inner diameter of the referenced devices at the supplier, Bal Seal.
P970003/S184
8/28/15
VNS Therapy Lead
Cyberonics, Inc.
Houston, TX
77058
Removal of an acetone and isopropyl alcohol pre-conditioning treatment step in the manufacture of your Model 302 Leads for the VNS Therapy System.
P980003/S062
8/19/15
Chilli II Cooled Ablation Catheter
Boston Scientific Corporation
San Jose, CA
95134
Acceptance for a change of equipment used during leak testing.
P980007/S040
8/13/15
ARCHITECT Free PSA
Abbott Laboratories
Abbott Park, IL 60064
Replace the polypropylene resin used in the manufacture of ARCHITECT Reaction Vessels.
P980016/S542
8/19/15
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
Change for the connector molding manufacturing process for the devices.
P980016/S543
8/20/15
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II, Maximo, Protecta ICD, Protecta, Protecta, Protecta, Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Manufacturing process changes for the battery used in the devices.
P980023/S073
8/31/15
Linox smart SD, Linox smart TD,
Linox smart Linox smart T65, Linox smart SDX, Protego SD, Protego Protego TD, Volta 1CR, Volta 1CT, Volta 2CR, Volta 2CT ICD’s
Biotronik, Inc.
Lake Oswego, OR 97035
Alternate supplier for the iridium coating process on the leads.
P980035/S433
8/18/15
Advisa DR IPG; Advisa DR MRI; Advisa SR MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Outsource three components from Medtronic Energy and Component Center (MECC) to an alternate supplier for the devices.
P010012/S396
8/8/15
INCEPTA™ CRT-Ds, ENERGEN™ CRT-Ds, PUNCTUA™
CRT-Ds, DYNAGEN™ CRT-Ds, INOGEN™
CRT-Ds, ORIGEN™
CRT-Ds
Boston Scientific
St. Paul, MN
55112
Add an additional inspection step to pulse generator case half manufacturing, along with associated specification and inspection criteria, that will allow pulse generator case half discontinuities to be distinguished from dents.
P010012/S397
8/21/15
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
Boston Scientific Corporation
Saint Paul, MN 55112
Addition of an alternate semi-automated ‘thickness and loading’ process step to the battery manufacturing line.
P010015/S276
8/18/15
Consulta CRT-P; Syncra CRT-P; Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Outsource three components from Medtronic Energy and Component Center (MECC) to an alternate supplier for the devices.
P010019/S040
8/28/15
Lotrafilcon B Soft Contact Lenses for Extended Wear
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Change to the APHA color specification.
P010030/S065
8/22/15
LifeVest Wearable Defibrillators
Zoll Manufacturing Corporation
Pittsburgh, PA 15238
Addition of an alternate supplier, Carclo Technical Plastics (CTP) Latrobe, PA, for the Therapy Electrode Gel Blister Cover.
P010031/S506
8/19/15
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 CRT-D, Viva S CRT-D,
Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Change for the connector molding manufacturing process for the devices.
P010031/S507
8/20/15
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 CRT-D, Viva S CRT-D,
Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Manufacturing process changes for the battery used in the devices.
P010068/S048
8/18/15
Celsius FLTR Bi-Directional Ablation Catheter
Biosense Webster, Inc.
Diamond Bar, CA 91765
Acceptance of a new production machine for performing reflow of the quad lumen tip.
P020004/S120
8/14/15
Gore EXCLUDER AAA Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Implement use of a new burst test machine.
P030005/S128
8/8/15
Valitude CRT-P
Boston Scientific CRM
St. Paul, MN
55112
Add an automated vision inspection system for the coil spring inner diameter of the referenced devices at the supplier, Bal Seal.
P030017/S231
8/25/15
Precision Spectra Spinal Cord Stimulator (SCS) System
Boston Scientific Corporation
Valencia, CA
91355
Modification to the plasma cleaning parameters used during the manufacturing process.
P030031/S069
8/6/15
ThermoCool SmartTouch Navigation Catheter
Biosense Webster, Inc.
Diamond Bar, CA
91765
Additional supplier for the catheter tip electrode.
P030031/S070
8/18/15
ThermoCool SmartTouch Uni-Directional Ablation Catheter
Biosense Webster, Inc.
Diamond Bar, CA 91765
Acceptance of a new production machine for performing reflow of the quad lumen tip.
P030034/S008
8/26/15
Cervical-Stim®
Orthofix
Lewisville, TX 75056
Implementation of an alternate machine to produce transducer coils (Cervical-Stim only) and remove redundant inspection of various device components.
P030036/S079
8/18/15
SelectSecure Lead
Medtronic, Inc.
Mounds View, MN 55112
Outsource three components from Medtronic Energy and Component Center (MECC) to an alternate supplier for the devices.
P040008/S012
8/5/15
VIDAS® Total PSA
bioMérieux, Inc.
Hazelwood, MO
63042
Addition of an alternate qualified supplier for the VIDAS strips.
P040024/S081
8/31/15
Restylane®, Restylane-L®, Perlane®, Restylane® Silk, Restylane® Lyft Injectable Gels
Galderma Laboratories, L.P.
Fort Worth, TX 76177
Site change for the sterilization of empty Hypak syringes.
P040027/S045
8/14/15
Gore VIATORR TIPS Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Implement use of a new burst test machine.
P040036/S051
8/6/15
ThermoCool SmartTouch Navigation Catheter
Biosense Webster, Inc.
Diamond Bar, CA
91765
Additional supplier for the catheter tip electrode.
P040036/S052
8/18/15
ThermoCool SmartTouch Bi-Directional Ablation Catheter
Biosense Webster, Inc.
Diamond Bar, CA 91765
Acceptance of a new production machine for performing reflow of the quad lumen tip.
P040037/S084
8/4/15
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Implementation of a supplier process change to the temperature setting of the curing oven used in the manufacturing process of a catheter component.
P040037/S085
8/14/15
Gore VIABAHN Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Implement use of a new burst test machine.
P040043/S075
8/14/15
Gore TAG Thoracic Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Implement use of a new burst test machine.
P040044/S065
8/3/15
Mynx Ace Vascular Closure Device
Access Closure, Inc.
Santa Clara, CA
95054
Addition of a secondary contract sterilizer.
P050017/S012
8/31/15
Zilver Vascular Stent
Cook Medical Incorporated
Bloomington, IN 47402
Modifications to the manufacture of the handle assembly of the delivery system.
P050042/S032
8/13/15
ARCHITECT Anti-HCV
Abbott Laboratories
Abbott Park, IL 60064
Replace the polypropylene resin used in the manufacture of ARCHITECT Reaction Vessels.
P050051/S030
8/13/15
ARCHITECT AUSAB
Abbott Laboratories
Abbott Park, IL 60064
Replace the polypropylene resin used in the manufacture of ARCHITECT Reaction Vessels.
P060035/S025
8/13/15
ARCHITECT CORE-M
Abbott Laboratories
Abbott Park, IL 60064
Replace the polypropylene resin used in the manufacture of ARCHITECT Reaction Vessels.
P060040/S43
8/20/15
Thoratec Heartmate II Ventricular Assist System
Thoratec Corporation
Pleasanton, CA 94588
Qualify an alternate manufacturing site for the Bend Relief of the cannula.
P070008/S068
8/31/15
Corox OTW, Celerity 2D,
Celerity 3D,
Celerity Pilot ICD’s
Biotronik, Inc.
Lake Oswego, OR 97035
Alternate supplier for the iridium coating process on the leads.
P070016/S010
8/3/15
Zenith TX2 TAA Endovascular Graft
Cook, Inc.
Bloomington, IN
47402
Change to the coating process parameters for the release-wires.
P070027/S043
8/20/15
Talent Occluder With Occluder Delivery System
Medtronic Vascular Inc.
Santa Rosa, CA
95403
Relocation of a supplier’ manufacturing operations.
P080020/S016
8/28/15
Gel-One®
Seikagaku Corporation
Tokyo, Japan
100-0005
Addition of a new conductivity meter and auto-sampler system for monitoring the quality of water for injection.
P080020/S017
8/28/15
Gel-One®
Seikagaku Corporation
Tokyo, Japan
100-0005
Implementation of a new control and alert system for monitoring and recording the critical speeds during manufacturing of a component of Gel-One®.
P080023/S027
8/13/15
ARCHITECT CORE
Abbott Laboratories
Abbott Park, IL 60064
Replace the polypropylene resin used in the manufacture of ARCHITECT Reaction Vessels.
P090013/S195
8/18/15
Revo MRI SureScan IPG
Medtronic, Inc.
Mounds View, MN 55112
Outsource three components from Medtronic Energy and Component Center (MECC) to an alternate supplier for the devices.
P100013/S012
8/20/15
Cordis® EXOSEAL® Vascular Closure Device
Cordis Corporation
Fremont, CA
94555
Addition of an alternate supplier for a component of the 5F, 6F and 7F EXOSEAL Vascular Closure Devices (VCDs).
P100021/S048
8/7/15
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System
Medtronic, Inc.
Santa Rosa, CA
95403
Replacement of the current V-block fixture at Vention Medical with a new Delrin fixture to facilitate T-tube subassembly inspections.
P100040/S023
8/20/15
Valiant Thoracic Stent Graft with Captivia Delivery System, Valiant Thoracic Stent Graft with Captivia Delivery System (FreeFlo Tapered Stent Grafts)
Medtronic Vascular Inc.
Santa Rosa, CA
95403
Relocation of a supplier’s manufacturing operations.
P100047/S065
8/27/15
Heartware Left Ventricular Assist System
Heartware, Inc.
Miami Lakes, FL 33014
Modifications to the in-process inspections for the sewing rings.
P110013/S053
8/12/15
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Medtronic, Inc.
Galway, Ireland
Change in the cleaning solvent for utensils used during the drug spray process of the product.
P110013/S054
8/19/15
Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems
Medtronic, Inc.
Santa Rosa, CA 95403
Modifications to the analytical test methods that are performed as part of the quality control analytical batch release testing.
P110029/S022
8/13/15
ARCHITECT HBsAg Qualitative/ARCHITECT HBsAg Qualitative Confirmatory
Abbott Laboratories
Abbott Park, IL 60064
Replace the polypropylene resin used in the manufacture of ARCHITECT Reaction Vessels.
P110042/S049
8/21/15
Gen2.0 S-ICD
Boston Scientific Corporation
Saint Paul, MN 55112
Addition of an alternate semi-automated ‘thickness and loading’ process step to the battery manufacturing line.
P120006/S021
8/7/15
Ovation Abdominal Stent Graft System, Ovation Prime Abdominal Stent Graft System, Ovation iX Iliac Stent Graft
TriVascular, Inc.
Santa Rosa, CA 95403
Change to the pyrogen sampling plan for finished product release of ethylene oxide (EO) sterilized product in the Ovation stent graft/delivery system family.
P120008/S009
8/13/15
ARCHITECT AFP
Abbott Laboratories
Abbott Park, IL 60064
Replace the polypropylene resin used in the manufacture of ARCHITECT Reaction Vessels.
P120011/S001
8/27/15
Ideal Implant Saline Filled Breast Implant
Ideal Implant Incorporated
Dallas, TX
75244
An increase in the scale and capacity of shell production equipment, and the elimination for the need of the contract manufacturer to dilute the silicone dispersion material.
P130006/S023
8/4/15
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Implementation of a supplier process change to the temperature setting of the curing oven used in the manufacturing process of a catheter component.
P130006/S024
8/14/15
Gore VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Implement use of a new burst test machine.
P130007/S006
8/10/15
Animas Vibe System
Animas Corporation
West Chester, PA 19380
Change to the molding press equipment for several Animas Vibe pump components. The Animas Vibe pump is a component of the Animas Vibe System.
P130007/S007
8/18/15
Animas Vibe System
Animas Corporation
West Chester, PA 19380
Change to the current Base Assembly process used for the manufacture of the pump base of the Animas Vibe system to improve overall manufacturing process efficiency. The proposed changes include removal of redundant test steps, separation of complex assembly operations into several discrete steps, and the addition of an identical assembly station.
P130009/S039
8/7/15
Edwards SAPIEN XT Transcatheter Heart Valve and Accessories
Edwards Lifesciences, LLC
Irvine, CA
92614
Extend the application area of the currently approved adhesive at the Y-connector to guidewire shaft bond of the Ascendra+ delivery system and add a quality inspection of the adhesive at both the Y-connector to guidewire shaft and Y-connector to balloon shaft bond sites.
P130009/S040
8/7/15
Edwards SAPIEN XT Transcatheter Heart Valve and Accessories
Edwards Lifesciences, LLC
Irvine, CA
92614
Extend the shelf life of the polytetrafluoroethylene sewing thread from 5 years to 10 years.
P130021/S017
8/27/15
Medtronic CoreValve System
Medtronic CardioVascular
Santa Rosa, CA 95403
Reduce the sample size used for bacterial endotoxin testing on the EnVeo R Delivery Catheter System component of the Medtronic CoreValve Evolute R System.
P140031/S001
8/7/15
Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories
Edwards Lifesciences, LLC
Irvine, CA
92614
Extend the shelf life of the polytetrafluoroethylene sewing thread from 5 years to 10 years.
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