The FDA today released its list of the pre-market approvals it granted for medical devices in May 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 51
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 26
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 547
Total Active: 379
Total On Hold: 168
Summary of All PMA Submissions
Originals: 1
Supplements: 62
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 51
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 109.5
FDA Time: 86.4 Days
MFR Time: 23.1 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P130022
5/8/15
Nevro Senza Spinal Cord Stimulation (SCS) System
Nevro Corporation
Menlo Park, CA 94025
Approval for the Nevro Senza SCS System. This device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain.
P140002
5/22/15
Misago Peripheral Self-Expanding Stent System
Terumo Medical Corporation
Elkton, MD
21921
Approval for the Misago Peripheral Self-expanding Stent System. This device is indicated to improve luminal diameter in symptomatic patients with de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters ranging from 4mm to 7mm and lesion length up to 150mm.
P140004
5/20/15
Superion® InterSpinous Spacer (ISS)
VertiFlex®, Incorporated
San Clemente, CA
92673
Approval for the Superion InterSpinous Spacer (ISS). This device is indicated to treat skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of moderate degenerative lumbar spinal stenosis, with or without Grade 1 spondylolisthesis, confirmed by X-ray, MRI and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion® ISS is indicated for those patients with impaired physical function who experience relief in flexion from symptoms of leg/buttock/groin pain, numbness, and/or cramping, with or without back pain, and who have undergone at least 6 months of non-operative treatment. The Superion® ISS may be implanted at one or two adjacent lumbar levels in patients in whom treatment is indicated at no more than two levels, from L1 to L5. For this intended use, moderate degenerative lumbar spinal stenosis was defined as follows: 1) 25% to 50% reduction in the central canal and/or nerve root canal (subarticular, neuroforaminal) compared to the adjacent levels on radiographic studies, with radiographic confirmation of any one of the following: a) Evidence of thecal sac and/or cauda equina compression; b) Evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements; and c) Evidence of hypertrophic facets with canal encroachment. 2) and associated with the following clinical signs: a) Presents with moderately impaired Physical Function (PF) defined as a score of ≥ 2.0 of the Zurich Claudication Questionnaire (ZCQ); and b) Ability to sit for 50 minutes without pain and to walk 50 feet or more.
P140023
5/7/15
cobas® KRAS Mutation Test
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for the cobas KRAS Mutation Test. This device is indicated for the following: The cobas KRAS Mutation Test, for use with the cobas 4800 System, is a real-time PCR test for the detection of seven somatic mutations in codons 12 and 13 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC) tumor tissue. The test is intended to be used as an aid in the identification of CRC patients for whom treatment with Erbitux (cetuximab) or with Vectibix (panitumumab) may be indicated based on a no mutation detected result. Specimens are processed using the cobas DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.
P140026
5/18/15
ENROUTE™ Transcarotid Stent System
Silk Road Medical, Inc.
Sunnyvale, CA 94085
Approval for the ENROUTE™ Transcarotid Stent System. This device is indicated for use in conjunction with the ENROUTE Transcarotid Neuroprotection System (NPS) for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below. 1) Patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; 2) Patients must have a vessel diameter of 4-9mm at the target lesion; and 3) Carotid bifurcation is located at minimum 5 cm above the clavicle to allow for placement of the ENROUTE Transcarotid NPS
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
N18033/S076
5/1/15
VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical) Clear and Tinted with UV Blocker, VISTAKON (etafilcon A) BIFOCAL Soft (hydrophilic) Contact Lens Clear and Tinted with UV Blocker, VISTAKON (etafilcon A) TORIC Soft (hydrophilic) Contact Lens Clear and Tinted with UV Blocker, VISTAKON (etafilcon A) BIFOCAL-TORIC Soft (hydrophilic) Contact Lens Clear and Tinted with UV Blocker, VISTAKON (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses
Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Implementation of a second supplier source for the primary package blister bowl.
N18033/S077
5/5/15
VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical) Clear and Tinted with UV Blocker, VISTAKON (etafilcon A) BIFOCAL Soft (hydrophilic) Contact Lens Clear and Tinted with UV Blocker, VISTAKON (etafilcon A) TORIC Soft (hydrophilic) Contact Lens Clear and Tinted with UV Blocker, VISTAKON (etafilcon A) BIFOCAL-TORIC Soft (hydrophilic) Contact Lens Clear and Tinted with UV Blocker, VISTAKON (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses
Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Implement an alternate supplier for the cure bulb used in the manufacture of Vistakon® (etafilcon A) and Vistakon® (senofilcon A) Brand Contact Lenses.
P830055/S156
5/26/15
LCS® Total Knee System
Depuy Orthopaedics, Incorporated
Warsaw, IN
46581
Changes to the product inspection – Use of an overlay as a tool on the comparator to assist the associate in determining if the part conforms to specifications for peg groove location.
P830061/S120
5/14/15
CapSure Sense Leads
Medtronic Inc.
Mounds View, MN 55112
Updated bioburden test methods for the implantable pulse generator and lead models for the devices.
P830061/S121
5/4/15
Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence PS+ Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P840001/S300
5/18/15
Restore, Itrel, and Synergy Spinal Cord Stimulation (SCS) Systems and Pisces, Specify, and Vectris SCS Leads
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Replace the legacy systems used at the firm’s Puerto Rico facilities with a newer, state-of-the art system.
P850089/S114
5/4/15
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P860004/S227
5/18/15
SynchroMed Infusion System
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Replace the legacy systems used at the firm’s Puerto Rico facilities with a newer, state-of-the art system.
P880081/S039
5/1/15
TECNIS® CL Foldable Silicone IOL
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Implementation of a new method for measurement of the optical properties (diopter and image quality) of the 3-piece acrylic and silicone IOLs produced at AMO’s Puerto Rico facility.
P880086/S256
5/14/15
Allure and Allure Quadra Family of CRT-P Devices
St. Jude Medical
Sylmar, CA
91342
Addition of an alternate supplier of low voltage hybrid assemblies.
P890003/S331
5/4/15
Prodigy IPG, CapSure VDD 2 Lead, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S+ VDD Lead and Vitatron Brilliant S+VDD Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P900056/S146
5/28/15
Rotablator® Rotational Angioplasty System Guidewire
Boston Scientific Corporation
Maple Grove, MN 55311
Update to software and vacuum pump settings used in the sterilization chamber.
P900061/S135
5/4/15
End Cap, Epicardial Patch Lead and Upsizing Sleeve
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P920015/S153
5/4/15
Sprint Quattro Lead, Subcutaneous Lead, Transvene CS/SVC Lead , DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit,
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P920047/S079
5/11/15
Blazer II, Blazer II HTD, Blazer Prime HTD
Boston Scientific Corporation
San Jose, CA
95134
Acceptance of new monitoring equipment in the microbiology lab at the Heredia, Costa Rica location.
P920047/S081
5/28/15
Blazer II™ Cardiac Ablation Catheter and Cable
Boston Scientific Corporation
Maple Grove, MN 55311
Update to software and vacuum pump settings used in the sterilization chamber.
P930014/S079
5/5/15
AcrySert® C Delivery System
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Alternative supplier for the polypropylene resin material for the AcrySert® C Delivery System.
P930029/S051
5/4/15
RF Contactr, RF Enhancr II, RF Conductr, RF Marinr 5F, and RF Marinr 7Fr
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P930039/S128
5/14/15
CapSureFix Novus Leads
Medtronic Inc.
Mounds View, MN 55112
Updated bioburden test methods for the implantable pulse generator and lead models for the devices.
P930039/S129
5/4/15
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, and Vitatron Crystalline Active Fixation Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P950024/S064
5/4/15
CapSure Epicardial Pacing Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P950037/S152
5/14/15
CardioMessenger LLT Kit, CardioMessenger TLine Kit, Refurbished 350939 CardioMessenger LLT, Refurbished 358225 CardioMessenger TLine, Battery cartridge, Reliaty Pacing System Analyzer, Reliaty complete kit (Model 365530), Reliaty complete kit, refurbished, Renamic Complete Kit, Renamic Pen, Renamic PGH, Renamic PGH ICD, Renamic Programmer, Renamic Programmer, Renamic PSA Module (device), Renamic PSA Module (kit), Reocor D, Reocor S, Reocor D Redel Adapter, Reocor S Redel Adapter
BIOTRONIK, Inc.
Lake Oswego, OR 97035
Addition of a new supplier for printed circuit boards.
P960004/S068
5/14/15
FINELINE™ II Sterox, FINELINE™ II Sterox EZ
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul, MN
55112
Replace the pace/sense lead anode insulator tubing hole diameter verification inspection process with a validated manufacturing process.
P960009/S225
5/18/15
Activa Deep Brain Stimulation (DBS) Therapy System
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Replace the legacy systems used at the firm’s Puerto Rico facilities with a newer, state-of-the art system.
P960009/S226
5/18/15
Activa Deep Brain Stimulation Therapy System
Medtronic Neuromodulation
Minneapolis, MN 55432
Changes to the final function electrical continuity test for leads.
P960016/S054
5/11/15
Livewire TC Cardiac Ablation System
St. Jude Medical
Plymouth, MN 55442
Acceptance of a new mechanized braze process for the Livewire TC Ablation Catheter.
N970003/S173
5/19/15
ESSENTIO™ Pacemakers, PROPONENT™ Pacemakers, ACCOLADE™ Pacemakers ALTRUA 2™ Pacemakers
Boston Scientific Corporation
Saint Paul, MN 55112
Modify the crystal oscillator manufacturing process at an existing supplier for the devices.
N970003/S174
5/19/15
ESSENTIO™ Pacemakers, PROPONENT™ Pacemakers, ACCOLADE™ Pacemakers, ALTRUA 2™ Pacemaker
Boston Scientific Corporation
St. Paul, MN
55112
Modify the crystal oscillator manufacturing process for the pulse generator devices at an existing supplier.
N970003/S176
5/31/15
Ingenio 2
Boston Scientific Corporation
St. Paul, MN
55112
Add an alternate source supplier for the anode battery raw material, stainless steel ribbon.
P970004/S198
5/18/15
InterStim Therapy System
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Replace the legacy systems used at the firm’s Puerto Rico facilities with a newer, state-of-the art system.
N970012/S108
5/6/15
AMS 700 Inflatable Penile Prosthesis
American Medical Systems, Inc.
Minnetonka, MN 55343
Addition of three (3) duplicate ovens as back-up equipment.
P980003/S059
5/28/15
Chilli II™ Cooled Ablation Catheter and Cable
Boston Scientific Corporation
Maple Grove, MN 55311
Update to software and vacuum pump settings used in the sterilization chamber.
P980016/S538
5/4/15
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic ICD, Marquis DR ICD, Marquis VR ICD, Maximo DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD, Protecta XT ICD, Secura ICD and Virtuoso II DR/VR ICD
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P980018/S019
5/21/15
HercepTest™
Dako Denmark A/S
Glostrup, Denmark
DK-2600
Modify the In Process Quality Control (IPC) test to verify the performance of bulk reagents (intermediates) DAB+ Buffered Substrate and DAB+ Chromogen.
P980035/S422
5/14/15
Adapta, Versa, Sensia IPGs, Relia IPGs
Medtronic Inc.
Mounds View, MN 55112
Updated bioburden test methods for the implantable pulse generator and lead models for the devices.
P980035/S423
5/4/15
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG and Advisa SR MRI IPG
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P980040/S061
5/1/15
SENSAR® Soft Acrylic Intraocular Lenses (IOLs)
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Implementation of a new method for measurement of the optical properties (diopter and image quality) of the 3-piece acrylic and silicone IOLs produced at AMO’s Puerto Rico facility.
P980050/S100
5/4/15
Transvene CS/SVC Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P990046/S040
5/15/15
Medtronic Open Pivot™ Aortic Valved Graft
Medtronic, Inc.
Minneapolis, MN 55447
New alanine dosimetry system at Steris Isomedix Services (Libertyville, Illinois).
P990080/S039
5/1/15
TECNIS® Acrylic IOL
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Implementation of a new method for measurement of the optical properties (diopter and image quality) of the 3-piece acrylic and silicone IOLs produced at AMO’s Puerto Rico facility.
P000053/S059
5/6/15
AMS 800 Urinary Control System
American Medical Systems, Inc.
Minnetonka, MN 55343
Addition of three (3) duplicate ovens as back-up equipment.
P010015/S272
5/4/15
Attain Bipolar OTW Lead and Attain OTW Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P010019/S038
5/5/15
Night & Day® and Air Optix Night and Day® Aqua (lotrafilcon A) Soft Contact Lenses for Extended Wear
O2Otix™, Air Optix® Aqua, Air Optix® for Astigmatism, and Air Optix® Aqua Multifocal (lotrafilcon B) Soft Contact Lenses for Extended Wear
Alcon Laboratories, Inc.
Fort Worth TX 76134
Changing the NaCl ion permeability test to correct for variable thickness lenses and the associated software update.
P010019/S039
5/28/15
Lotraficon B Soft Contact Lenses for Extended Wear
Night & Day®, Air Optix Night & Day® Aqua, O2Optix™, Air Optix® Aqua, Air Optix® for Astigmatism, Air Optix® Aqua Multifocal
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Implementation of modifications to the packaging and quality control testing of a raw material.
P010020/S032
5/6/15
AMS Acticon Neosphincter Artificial Bowel Sphincter
American Medical Systems, Inc.
Minnetonka, MN 55343
Addition of three (3) duplicate ovens as back-up equipment.
P010029/S024
5/7/15
EUFLEXXA (1% Sodium Hyaluronate)
Ferring Pharmaceuticals, Inc.
Parsippany, NJ 07054
Scale up the manufacturing process of EUFLEXXA by increasing the formulation capacity.
P010031/S501
5/4/15
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, 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, and Viva XT CRT-D
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P020004/S113
5/7/15
Gore Excluder AAA Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Boxing process change in which the IFU packet is placed in the product box prior to sterilization.
P020004/S114
5/27/15
Gore Excluder AAA Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Revised destructive testing sampling plan for C3 delivery catheters.
P020004/S115
5/27/15
GORE® EXCLUDER® AAA Endoprosthesis
W.L. Gore and Associates, Inc.
Flagstaff, AZ
86001
Implement an additional packaging location.
P020011/S008
5/8/15
APTIMA® HCV RNA Qualitative Assay
Hologic, Incorporated
San Diego, CA 92121
Qualification and introduction of a new manufacturing filling system.
P020025/S070
5/11/15
Blazer II XP, Blazer Prime XP, IntellaTip MiFi XP
Boston Scientific Corporation
San Jose, CA
95134
Acceptance of new monitoring equipment in the microbiology lab at the Heredia, Costa Rica location.
P020025/S071
5/28/15
Blazer II™ XP Cardiac Ablation Catheter and Cable
Boston Scientific Corporation
Maple Grove, MN 55311
Update to software and vacuum pump settings used in the sterilization chamber.
P020050/S022
5/5/15
Wavelight Ex500 Laser System
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Qualify an alternate supplier for calibration targets used for the WaveLight EX500 laser system.
P030005/S120
5/19/15
VALITUDE™ CRT-P
Boston Scientific Corporation
Saint Paul, MN 55112
Modify the crystal oscillator manufacturing process at an existing supplier for the devices.
P030005/S121
5/19/15
VALITUDE™ CRT-P
Boston Scientific Corporation
St. Paul, MN
55112
Modify the crystal oscillator manufacturing process for the pulse generator devices at an existing supplier.
P030005/S123
5/31/15
Ingenio 2
Boston Scientific Corporation
St. Paul, MN
55112
Add an alternate source supplier for the anode battery raw material, stainless steel ribbon.
P030008/S020
5/5/15
Wavelight Ex500 Laser System
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Qualify an alternate supplier for calibration targets used for the WaveLight EX500 laser system.
P030017/S222
5/4/15
Precision® Spinal Cord Stimulator (SCS) System
Boston Scientific Corporation
Neuromodulation
Valencia, CA
91355
Addition of an alternate component supplier.
P030017/S223
5/11/15
Precision Spectra TM Spinal Cord Stimulator (SCS) System
Boston Scientific Corporation
Neuromodulation
Valencia, CA
91355
Changing the electronic assembly process sequence used in the printed circuit board assembly (pcba) of the precision spectra implantable pulse generator ipg.
P030017/S224
5/7/15
Precision Spectra™ Spinal Cord Stimulator (SCS) System
Boston Scientific Corporation
Neuromodulation
Valencia, CA
91355
Update test equipment software.
P030017/S226
5/29/15
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems
Boston Scientific Corporation
Neuromodulation
Valencia, CA
91355
Process changes for the nickel strips in the IPG battery.
P030035/S134
5/14/15
Assurity, Assurity+ and Endurity Family of Pacemaker Devices
St. Jude Medical
Sylmar, CA
91342
Addition of an alternate supplier of low voltage hybrid assemblies.
P030036/S078
5/4/15
Anchoring Sleeve Kit and SelectSecure Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P030047/S031
5/28/15
Cordis® PRECISE® Nitinol Stent System
Cordis Corporation
Fremont, CA
94555
Use an alternate stabilizing additive in plastic compounding processes.
P030053/S028
5/8/15
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants
Mentor Worldwide LLC
Santa Barbara, CA 93111
Change to use segregation baskets for in-process shell component in the production of MemoryShape, and MemoryGel Silicone Gel-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility.
P040014/S025
5/20/15
Therapy Ablation Catheter including Bi-Directional Catheter and Therapy 4mm Thermistor Ablation Catheter
Irvine Biomedical, Inc.
Irvine, CA
92614
Change in manufacturing room location of the band electrode sub-assembly.
P040027/S042
5/27/15
GORE® VIATORR® TIPS Endoprosthesis
W.L. Gore and Associates, Inc.
Flagstaff, AZ
86001
Implement an additional packaging location.
P040037/S077
5/7/15
GORE® VIABAHN® Endoprosthesis & GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
W.L. Gore and Associates
Flagstaff, AZ
86001
Implement the use of new equipment for one of the delivery system components.
P040042/S030
5/20/15
Therapy Dual 8 Ablation Catheter, Therapy 8mm Thermistor Ablation Catheter, Safire TX Ablation Catheter
Irvine Biomedical, Inc.
Irvine, CA
92614
Change in manufacturing room location of the band electrode sub-assembly.
P040043/S073
5/7/15
Gore Tag Thoracic Endoprosthesis
W. L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Implement an optional graft wrapper machine.
P040045/S050
5/1/15
VISTAKON (senofilcon A) Soft (hydrophilic) Contact Lens (spherical),
VISTAKON (senofilcon A) Multifocal Soft (hydrophilic) Contact,
VISTAKON (senofilcon A) Toric Soft (hydrophilic) Contact Lens,
VISTAKON (senofilcon A) Multifocal-Toric Soft (hydrophilic) Contact Lens,
VISTAKON (senofilcon A) UV Blocking Contact Lenses
Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Implementation of a second supplier source for the primary package blister bowl.
P040045/S051
5/5/15
VISTAKON (senofilcon A) Soft (hydrophilic) Contact Lens (spherical),
VISTAKON (senofilcon A) Multifocal Soft (hydrophilic) Contact,
VISTAKON (senofilcon A) Toric Soft (hydrophilic) Contact Lens,
VISTAKON (senofilcon A) Multifocal-Toric Soft (hydrophilic) Contact Lens,
VISTAKON (senofilcon A) UV Blocking Contact Lenses
Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Implement an alternate supplier for the cure bulb used in the manufacture of Vistakon® (etafilcon A) and Vistakon® (senofilcon A) Brand Contact Lenses.
P050023/S088
5/14/15
CardioMessenger II LLT Kit, Refurbished CardioMessenger II LLT, CardioMessenger II-S Kit, CardioMessenger II-S TLine Kit, CardioMessenger-S, CardioMessenger-S Tline, CardioMessenger II LLT Kit US, CardioMessenger II-S Kit, CardioMessenger II-S TLine Kit
BIOTRONIK, Inc.
Lake Oswego, OR 97035
Addition of a new supplier for printed circuit boards.
P050028/S046
5/8/15
COBAS® TaqMan HBV Test For Use With The High Pure System and
COBAS® AmpliPrep/
COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Incorporated
Pleasanton, CA 94588
Change in supplier for a component used in the production of COBAS TaqMan analyzers.
P050047/S047
5/22/15
Juvéderm Hyaluronate Gel Implants
Allergan, Inc.
Irvine, CA
92623
Changing the manual visual inspection process to an automated visual inspection process for the 1.0 mL syringes.
P060006/S067
5/28/15
Express® SD Monorail® Premounted Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Update to software and vacuum pump settings used in the sterilization chamber.
P060019/S031
5/20/15
Therapy Cool Path Ablation Catheters
Irvine Biomedical, Inc.
Irvine, CA
92614
Change in manufacturing room location of the band electrode sub-assembly.
P060028/S011
5/8/15
MEMORYSHAPE Breast Implants
Mentor Worldwide LLC
Santa Barbara, CA 93111
Change to use segregation baskets for in-process shell component in the production of MemoryShape, and MemoryGel Silicone Gel-filled Breast Implants manufactured at Mentor’s Irving, Texas Facility.
P060030/S047
5/8/15
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and
COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System
Roche Molecular Systems, Incorporated
Pleasanton, CA 94588
Change in supplier for a component used in the production of COBAS TaqMan analyzers.
P060039/S067
5/4/15
Attain StarFix Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P080006/S079
5/4/15
Attain Ability Lead and Attain Performa Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P080011/S037
5/21/15
Biofinity (comfilcon A) Soft (Hydrophilic) Extended-Wear Contact Lenses
CooperVision, Inc.
Pleasanton, CA 94588
Validation of Line #11 for manufacturing Biofinity Toric (comfilcon A) Soft (Hydrophilic) Extended-Wear Contact Lenses.
P080015/S012
5/29/15
Cervista® HPV 16/18
Hologic, Incorporated
San Diego, CA 92121
Additional manufacturing site for oligonucleotide components.
P080025/S093
5/18/15
InterStim Therapy System
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Replace the legacy systems used at the firm’s Puerto Rico facilities with a newer, state-of-the art system.
P090013/S185
5/14/15
CapSureFix MRI Lead
Medtronic Inc.
Mounds View, MN 55112
Updated bioburden test methods for the implantable pulse generator and lead models for the devices.
P090013/S186
5/4/15
Revo MRI SureScan IPG and CapSureFix MRI Lead
Medtronic Inc.
Mounds View, MN 55112
Use of a new enterprise system used in conjunction with various manufacturing processes.
P100009/S011
5/7/15
Mitraclip Clip Delivery System
Abbott Vascular, Inc.
Menlo Park, CA 94025
Add a dimensional measurement system.
P100023/S115
5/28/15
ION™ Paclitaxel-Eluting Coronary Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Update to software and vacuum pump settings used in the sterilization chamber.
P100045/S005
5/22/15
CardioMEMS HF System
St. Jude Medical
Atlanta, GA
30313
Alternate supplier for skiving, tipping, coating, hub bond, and hub assembly tasks performed in manufacturing the PA Delivery Catheter.
P110010/S106
5/28/15
PROMUS Element™ Plus Everolimus-Eluting Stent System/ Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Update to software and vacuum pump settings used in the sterilization chamber.
P110016/S017
5/20/15
Therapy Cool Path Duo Ablation Catheter and Therapy Cool Flex Ablation Catheter
Irvine Biomedical, Inc.
Irvine, CA
92614
Change in manufacturing room location of the band electrode sub-assembly.
P110033/S014
5/22/15
Juvéderm Voluma XC
Allergan, Inc.
Irvine, CA
92623
Changing the manual visual inspection process to an automated visual inspection process for the 1.0 mL syringes.
P110037/S021
5/8/15
COBAS® AmpliPrep/ COBAS® Taqman® CMV Test
Roche Molecular Systems, Incorporated
Pleasanton, CA 94588
Change in supplier for a component used in the production of COBAS TaqMan analyzers.
P120002/S034
5/28/15
Cordis® SMART® and SMART® Control® Vascular Stent Systems
Cordis Corporation
Fremont, CA
94555
Use an alternate stabilizing additive in plastic compounding processes.
P120010/S034
5/28/15
Cordis® SMART® and SMART® Control® Nitinol Stent Systems
Cordis Corporation
Fremont, CA
94555
Use an alternate stabilizing additive in plastic compounding processes.
P120010/S066
5/15/15
MiniMed 530G System
Medtronic MiniMed
Northridge, CA 91325
Increase in the shelf life for the Enlite Glucose Sensor subassembly (sensor base and caps) after plasma treatment, and an increase in the load (number) of treated Enlite sensor subassemblies per plasma treatment cycle. The Enlite glucose sensor is a component of the MiniMed 530G System.
P120020/S008
5/12/15
Supera Peripheral Stent System
Abbott Vascular, Inc.
Santa Clara, CA 95054
Move the endotoxin testing prior to sterilization.
P130006/S016
5/7/15
GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
W.L. Gore and Associates
Flagstaff, AZ
86001
Implement the use of new equipment for one of the delivery system components.
P130030/S012
5/28/15
REBEL™ Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire)
Boston Scientific Corporation
Maple Grove, MN 55311
Update to software and vacuum pump settings used in the sterilization chamber.
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
P850064/S023
5/15/15
180-Day
Life Pulse High Frequency Ventilator
Bunnell, Inc.
Salt Lake City, UT 84115
Approval for the change the thermistor in the Patient Circuit used with the Life Pulse High Frequency Ventilator.
P890003/S328
5/4/15
Real-Time
Medtronic MyCareLink Smart Reader
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the Medtronic Model 25000 MyCareLink Smart Reader for use with the devices.
P890064/S032
5/29/15
180-Day
digene® Hybrid Capture 2 (HC2) HPV DNA Test and
digene® Hybrid Capture 2 (HC2) High-Risk HPV DNA Test
QIAGEN Incorporated
Germantown, MD 20874
Approval for a manufacturing site located in Penang, Malaysia.
P900056/S144
5/12/15
135-Day
Rotablator Rotational Angioplasty System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval to update inspection requirements: remove duplicate inspection steps and reduction in the frequency of selected equipment set-up inspections at the BSC Cork, Ireland site.
P920047/S080
5/29/15
Special
Blazer II and Blazer II HTD Temperature Ablation Catheters
Boston Scientific Corp.
San Jose, CA
95134
Approval to add an additional adverse event (Phrenic nerve damage) to the directions for use (DFU) warning section.
P930016/S044
5/6/15
Panel-Track
STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System
AMO Manufacturing USA, LLC
Milpitas, CA
95035
Approval for the STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System. This device uses a 6.0 mm optical zone, and 8.0 mm treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK) in patients: 1) with myopia as measured by the iDesign Advanced WaveScan Studio System up to -11 D spherical equivalent with up to -5 D cylinder; and 2) with agreement between manifest refraction (adjusted for optical infinity) and iDesign Advanced WaveScan Studio System refraction as follows: 1) Spherical Equivalent: Magnitude of the difference is less than 0.625 D; and 2) Cylinder: Magnitude of the difference is less than or equal to 0.5 D; a) 18 years of age or older; and b) with refractive stability (a change of ≤ 1.0 D in sphere or cylinder for a minimum of 12 months prior to surgery).
P960009/S220
5/11/15
Real-Time
Activa Deep Brain Stimulation (DBS) Therapy System
Medtronic Inc.
Minneapolis, MN 55432
Approval for material changes to two non-implantable screening cables (the Alligator Clip Screening Cable Accessory Kit and the Twist Lock Screening Cable Accessory Kit) to comply with the European Union Restriction of Hazardous Substances II Directive 2011/65/EU.
P960058/S112
5/19/15
180-Day
HiResolution Bionic Ear System, HiFocus Mid-Scala (HFMS) Insertion Tools
Advanced Bionics
Valencia, CA
91355
Approval for new suppliers for components of the HiFocus Mid-Scala Insertion Tools as well as changes to enhance the manufacturability of the tools at the new suppliers. and changes to the design and manufacture of the HiFocus Mid-Scala (HFMS) Insertion Tools.
P960058/S115
5/19/15
180-Day
HiResolution Bionic Ear System, New Insertion Tool Package
Advanced Bionics LLC
Valencia, CA
91355
Approval for a new configuration to the HiFocus Mid-Scala (HFMS) electrode instrument kit, namely a standalone HFMS Electrode Insertion Tool (Model Number CI-4207).
P970003/S173
5/29/15
180-Day
AspireSR Generator and Model 250 Version 11.0.5 Programming Software
Cyberonics, Inc.
Houston, TX
77058
Approval for the Model 106 AspireSR Generator and Model 250 Version 11.0.5 Programming Software.
P980016/S535
5/4/15
Real-Time
Evera S DR ICD, Evera S VR ICD. Evera XT DR ICD, Evera XT VR ICD, Entrust, Intrinsic 30 ICD, Intrinsic ICD, Marquis DR ICD, Marquis VR ICD, Maximo DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso DR/VR, and Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the Medtronic Model 25000 MyCareLink Smart Reader for use with the devices.
P980022/S166
5/13/15
Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, iPro2 Professional CGM System
Medtronic Minimed
Northridge, CA 91325
Approval for a change in the calculation method used to determine the amount of platinum to add in the manufacture of the Platinum solution used in the fabrication process for the Sof-Sensor and Enlite Sensors, and for the Enlite Sensor only, the addition of equipment used to verify the platinum solution concentration.
P980022/S178
5/19/15
Real-Time
MiniLink REAL-Time Continuous Glucose Monitoring System
Medtronic MiniMed
Northridge, CA 91325
Approval for a change to the shelf height dimensions of the watertight tester (MMT-7726), a component of the MiniLink REAL-Time Continuous Glucose Monitoring System and the MiniMed 530G System.
P980035/S415
5/4/15
Real-Time
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, EnRhythm, EnPulse E1 IPG, EnPulse E2 IPG, Kappa D (Kappa 700) IPG, Kappa D (Kappa 900) IPG, Kappa DR (Kappa 650) IPG, Kappa DR (Kappa 700/600) IPG, Kappa DR (Kappa 900/800) IPG, Kappa SR (Kappa 700) IPG, Kappa SR (Kappa 900) IPG, and Kappa VDD (Kappa 700) IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the Medtronic Model 25000 MyCareLink Smart Reader for use with the devices.
P980035/S420
5/27/15
Real-Time
Advisa DR IPG, Advisa SR MRI IPG, Advisa DR MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval of a change to the electronic module assembly specification.
P980037/S044
5/14/15
135-Day
Angiojet Rheolytic Thrombectomy Systems
Boston Scientific Corp.
Minneapolis, MN 55433
Approval of an alternate molded component vendor for the AngioJet family of Thrombectomy Sets.
P980040/S059
5/15/15
180-Day
SENSAR® 1-Piece Intraocular Lens (IOL)
Abbott Medical Optics Inc.
Santa Ana, CA 92705
Approval for labeling changes/revisions to the directions for use (DFU).for the SENSAR One-Piece Acrylic Posterior Chamber Intraocular Lens (IOL), Model AAB00.
P980044/S025
5/20/15
180-Day
SUPARTZ FX
Seikagaku Corporation
Tokyo, Japan
100-0005
Approval for a change of the trade name of the device from SUPARTZ to SUPARTZ FX. The device, as modified, will be marketed under the trade name SUPARTZ FX and 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 simple analgesics, e.g., acetaminophen.
P000008/S033
5/27/15
180-Day
LAPBAND™ Adjustable Gastric Banding
Apollo Endosurgery, Inc.
Austin, TX
78746
Approval for a post-approval study protocol.
P010014/S051
5/6/15
Special
Oxford Partial Knee System
Biomet UK Ltd
Swindon,
United Kingdom
SN3 5HY
Approval for additional inspection step.
P010015/S268
5/4/15
Real-Time
Consulta CRT-P and Syncra CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the Medtronic Model 25000 MyCareLink Smart Reader for use with the devices.
P010015/S270
5/27/15
Real-Time
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Approval of a change to the electronic module assembly specification.
P010023/S011
5/4/15
180-Day
MAXUM
Ototronix, LLC
St. Paul, MN
55127
Approval for changing the unaided air conduction threshold upper limits to 60, 70, and 85 dB HL at frequencies of 250, 500, and 1000 Hz, respectively, and to 100 dB HL at 2000, 3000, 4000, and 6000 Hz as part of the patient selection criteria.
P010031/S499
5/4/15
Real-Time
Brava CRT-D, Concerto ICD, Concerto II ICD, Consulta ICD, InSync II Protect ICD, InSync III Marquis ICD, InSync Maximo ICD, InSync Marquis, InSync Sentry, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D, and Brava CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the Medtronic Model 25000 MyCareLink Smart Reader for use with the devices.
P020045/S064
5/11/15
180-Day
CryoConsole
Medtronic CryoCath
Quebec, Canada H9R 5Z8
Approval for RoHS design and control changes to Gen V CryoConsole Model 106A3.
P020050/S019
5/1/15
180-Day
Allegro Topolyzer Vario
Alcon Laboratories, Inc.
Lake Forest, CA 92630
Approval to expand the approval of the Topolyzer VARIO to include its use as a diagnostic device supporting the WaveLight excimer lasers in performing T-CAT LASIK. The device, as modified, will be marketed under the trade name Allegro Topolyzer Vario and is indicated for the WaveLight ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight ALLEGRO Topolyzer (topographer) or ALLEGRO Topolyzer VARIO (topographer) and T-CAT treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (Topo-guided (T-CAT) LASIK): 1) for the reduction or elimination of up to -9.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -8.00 D of spherical component and up to -3.00 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as 0.50 D or less of preoperative spherical equivalent shift over one year prior to surgery.
P030005/S119
5/19/15
Real-Time
VALITUDE X4 CRT-P
Boston Scientific Corporation
St. Paul, MN
55112
Approval for design changes to the IS4 outer sleeve and vertical integration of IS4 outer sleeve manufacturing.
P030008/S017
5/1/15
180-Day
Allegro Topolyzer Vario
Alcon Laboratories, Inc.
Lake Forest, CA 92630
Approval to expand the approval of the Topolyzer VARIO to include its use as a diagnostic device supporting the WaveLight excimer lasers in performing T-CAT LASIK. The device, as modified, will be marketed under the trade name Allegro Topolyzer Vario and is indicated for the WaveLight ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight ALLEGRO Topolyzer (topographer) or ALLEGRO Topolyzer VARIO (topographer) and T-CAT treatment planning software is indicated for performing topography-guided laser assisted in situ keratomileusis (Topo-guided (T-CAT) LASIK): 1) for the reduction or elimination of up to -9.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -8.00 D of spherical component and up to -3.00 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as 0.50 D or less of preoperative spherical equivalent shift over one year prior to surgery.
P030017/S216
5/27/15
Real-Time
Precision® and Precision Spectra ™ Spinal Cord Stimulator (SCS) Systems
Boston Scientific Neuromodulation
Valencia, CA
91355
Approval for a minor design change to the Entrada Needle to be used with the SCS systems; specifically, requesting approval for the addition of a stylet cap cover to the needle design.
P030019/S004
5/5/15
135-Day
Orthovisc Injectable Intra-articular Device
Anika Therapeutics, Inc.
Bedford, MA
01730
Approval for an alternate raw material supplier.
P050019/S021
5/15/15
Real-Time
Carotid Wallstent Endoprosthesis
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for labeling changes related to the MR compatibility of the device.
P050023/S086
5/27/15
Real-Time
Lumax DR-T ICD, Lumax VR-T ICD, Lumax CRT-D
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for an alternate battery separator material.
P050028/S044
5/1/15
Real-Time
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for changes to the Magnetic Glass Particle (MGP) reagent bottles and closures.
P060011/S005
5/1/15
Real-Time
600C Aspheric Intraocular Lens
Rayner Intraocular Lenses Ltd.
East Sussex, United Kingdom
BN37AN
Approval for the following modifications of the C-flex Aspheric IOL Model 970C: 1) Increase of overall diameter from 12.00 mm to 12.50 mm; 2) increase of optic size from 5.75 mm to 6.00 mm; and 3) an extension of the high powered dioptric range from +30.0D to +34.0D. The device, as modified, will be marketed under the trade name 600C Aspheric Intraocular Lens and is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsificationThe lens is intended to be placed in the capsular bag.
P060030/S045
5/1/15
Real-Time
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test
version 2.0 For Use With The High Pure System
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for changes to the Magnetic Glass Particle (MGP) reagent bottles and closures.
P080013/S011
5/11/15
180-Day
DuraSeal Xact Sealant System
Integra Lifesciences Corporation
Plainsboro, NJ 08536
Approval of the following changes to the post-approval study for the device: 1) Change the definition of the minimum necessary follow-up from 60 to 45 days for the retrospective control subjects only; and 2) Allow any new study sites that do not have 90 day standard of care visits to enroll prospective subjects only (DuraSeal and/or Control). This will allow new sites to contribute subjects prospectively inside the study window (60 to 120 days), but exclude retrospective subjects that would potentially have been seen outside of the study window thus maintaining control over follow-up compliance.
P090013/S179
5/4/15
Real-Time
Revo MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the Medtronic Model 25000 MyCareLink Smart Reader for use with the devices.
P090015/S003
5/20/15
Special
Leica BOND Oracle HER2 IHC System
Leica Biosystems
Danvers, MA
01923
Approval for labelling changes to be complianct with the Regulation (EC) No 1272/2008 which applies to substances and mixtures classified as hazardous.
P090031/S004
5/5/15
135-Day
Monovisc Injectable Intra-articular Device
Anika Therapeutics, Inc.
Bedford, MA
01730
Approval for an alternate raw material supplier.
P100020/S013
5/1/15
Real-Time
cobas® HPV Test
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for changes to the Magnetic Glass Particle (MGP) reagent bottles and closures.
P100021/S047
5/6/15
Special
Endurant II Stent Graft System, Endurant IIs Stent Graft System
Medtronic Vascular Inc.
Santa Rosa, CA 95403
Approval for introducing a lamp mandrel as a manufacturing tool for the inspection of the radiopaque contralateral gate marker during the marker attachment process.
P100044/S017
5/7/15
180-Day
Propel and Propel Mini Sinus Implant
Intersect ENT
Menlo Park, CA 94025
Approval for a manufacturing site located at Synergy Health AST in Denver, Colorado.
P110004/S010
5/14/15
180-Day
NIRxcell CoCr Coronary Stent RX System
Medinol, Ltd.
Tel-Aviv, Israel
61591
Approval of the post-approval study protocol.
P110037/S019
5/1/15
Real-Time
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for changes to the Magnetic Glass Particle (MGP) reagent bottles and closures.
P120005/S031
5/22/15
Panel-Track
Dexcom G4™ PLATINUM (Pediatric) Continuous Glucose Monitoring System
Dexcom, Inc.
San Diego, CA 92121
Approval for the Dexcom G4™ PLATINUM (Pediatric) Continuous Glucose Monitoring System. This device is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes. The system is intended for single patient use and requires a prescription. The Dexcom G4 PLATINUM (Pediatric) System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Dexcom G4 PLATINUM (Pediatric) 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 G4 PLATINUM (Pediatric) System results should be based on the trends and patterns seen with several sequential readings over time.
P120006/S019
5/21/15
Real-Time
Ovation Prime Abdominal Stent Graft System, Ovation iX Iliac Stent Graft
TriVascular, Inc.
Santa Rosa, CA 95403
Approval for modifications to the outer diameters of the compression sleeves.
P120010/S040
5/13/15
Minimed 530G System
Medtronic Minimed
Northridge, CA 91325
Approval for a change in the calculation method used to determine the amount of platinum to add in the manufacture of the Platinum solution used in the fabrication process for the Sof-Sensor and Enlite Sensors, and for the Enlite Sensor only, the addition of equipment used to verify the platinum solution concentration.
P120010/S062
5/19/15
Real-Time
MiniMed 530G System
Medtronic MiniMed
Northridge, CA 91325
Approval for a change to the shelf height dimensions of the watertight tester (MMT-7726), a component of the MiniLink REAL-Time Continuous Glucose Monitoring System and the MiniMed 530G System.
P120014/S003
5/27/15
180-Day
THxID™-BRAF
bioMérieux SA
Craponne,
FRANCE
Approval for using the updated ABI 7500 Fast Dx operating system and SDS software.
P130005/S004
5/14/15
135-Day
Diamondback 360 Coronary Orbital Atherectomy System
Cardiovascular Systems, Inc.
St. Paul, MN
55112
Approval for a change to the sealing process for the nosecone-to-glue plug and glue plug-to-saline sheath bonds to use light within a narrower ultraviolet (UV) wavelength for curing the sealing adhesive.
P130026/S004
5/2/15
Special
Tacticath Quartz Set
St. Jude Medical
Plymouth, MN 55442
Approval for process changes to the TactiCath Quartz Catheter distal pullwire assembly.
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