The FDA today released its list of the pre-market approvals it granted for medical devices in September 2015:
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 53
Summary of PMA Originals Under Review
Total Under Review: 55
Total Active: 31
Total On Hold: 24
Summary of PMA Supplements Under Review
Total Under Review: 611
Total Active: 461
Total On Hold: 150
Summary of All PMA Submissions
Originals: 3
Supplements: 84
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 53
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 127.6
FDA Time: 90.9 Days
MFR Time: 36.9 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P100006
9/1/15
Augment® Bone Graft
Biomimetic Therapeutics, LLC
Franklin, TN
37067
Approval for Augment® Bone Graft. This device is indicated for use as an alternative to autograft in arthrodesis (i.e., surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients with preoperative or intraoperative evidence indicating the need for supplemental graft material.
P140005
9/2/15
GenVisc 850®
OrthogenRx, Incorporated
New Hope, PA 18938
Approval for GenVisc 850®. This device is indicated for or 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.
P140015
9/8/15
t:slim G4 Insulin Pump With Dexcom G4 Platinum CGM
Tandem Diabetes Care, Inc.
San Diego, CA
92121
Approval for the t:slim G4 Insulin Pump With Dexcom G4 Platinum CGM (“t:slim G4 System”). This device consists of the t:slim G4 Insulin Pump paired with the Dexcom G4 Platinum Sensor and Transmitter. The t:slim G4 Insulin Pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The t:slim G4 Insulin Pump can be used solely for continuous insulin delivery and as part of the t:slim G4 System to receive and display continuous glucose measurements from the Dexcom G4 Platinum Sensor and Transmitter. The t:slim G4 System also includes continuous glucose monitoring (CGM) indicated for detecting trends and tracking patterns in persons with diabetes for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The t:slim G4 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 t:slim G4 System results should be based on the trends and patterns seen with several sequential readings over time. The t:slim G4 System is indicated for use in individuals 12 years of age and greater. The t:slim G4 System is intended for single patient use and requires a prescription.
P140016
9/15/15
Zenith Alpha Thoracic Endovascular Graft
Cook Medical Incorporated
Bloomington, IN 47402
Approval for the Zenith Alpha Thoracic Endovascular Graft. This device is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair, including:
1) Iliac/femoral anatomy that is suitable for access with the required introduction systems; and
2) Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: a) with a length of at least 20 mm; and
b) with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P860004/S189
9/9/15
Real-Time
Synchromed II Implantable Infusion System
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes in manufacturing and requirements for the pump tube assembly.
P860004/S217
9/29/15
180-Day
Synchromed II Infusion Pump
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes affecting a gear train component (gear wheel 3) as well as a minor dimensional change to gear wheel 3 to enable manufacturing.
P860047/S031
9/25/15
180-Day
OcuCoat Ophthalmic Viscosurgical Device (OVD
Bausch & Lomb, Inc.
Irvine, CA
92688
Approval to change the cannula on the 1 mL OcuCoat 2% hydroxypropylmethylcellulose ophthalmic surgical device to a 25 gauge needle with a 32 degree bend.
P880086/S258
9/16/15
Real-Time
Assurity, Assurity+, Endurity, and Accent family of Pacemakers
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for updates to the Merlin@home EX2000 v8.1.1 Software for Models EX1150, EX1150W, EX1100, and EX1100W Transmitters.
P890003/S329
9/11/15
180-Day
CareLink Monitor, CardioSight Reader,
CareLink Express Monitor, MyCareLink Patient Monitor
Medtronic, Inc.
Mounds View, MN 55112
Approval of the Evera MRI XT/S DR and VR Implantable Cardioverter Defibrillator devices and programmer application software Model SW033 as well as extension of MR Conditional labeling and use for Sprint Quattro Secure lead Models 6935M and 6947M as MRI SureScan labeled 55 and 62cm leads. In addition to the system components listed, the use of the CapSureFix MRI SureScan Lead Model 5086MRI and CapSureFix Novus MRI SureScan Lead Model 5076 with the Evera MRI DR (dual chamber) system when an atrial pace/sense lead is indicated. Furthermore, you requested approval to use CareLink Monitor Model 2490C, CareLink Express Monitor 2020B, CardioSight Reader Model 2020A, MyCareLink Monitor Model 24950 and Device Data Management Application (DDMA) Model 2491 to provide patient and device data transfer from the Evera MRI devices.
P890003/S334
9/30/15
Real-Time
MyCareLink Monitor 24950
Medtronic, Inc.
Mounds View, MN 55112
Approval for minor design updates to the existing Telemetry M module to create an instrument only Telemetry M module.
P910023/S358
9/16/15
Real-Time
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, and Atlas/II/+ Family of ICDs
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for updates to the Merlin@home EX2000 v8.1.1 Software for Models EX1150, EX1150W, EX1100, and EX1100W Transmitters.
P920015/S151
9/11/15
180-Day
Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI
SureScan Lead
Medtronic, Inc.
Mounds View, MN 55112
Approval of the Evera MRI XT/S DR and VR Implantable Cardioverter Defibrillator devices and programmer application software Model SW033 as well as extension of MR Conditional labeling and use for Sprint Quattro Secure lead Models 6935M and 6947M as MRI SureScan labeled 55 and 62cm leads. In addition to the system components listed, the use of the CapSureFix MRI SureScan Lead Model 5086MRI and CapSureFix Novus MRI SureScan Lead Model 5076 with the Evera MRI DR (dual chamber) system when an atrial pace/sense lead is indicated. Furthermore, you requested approval to use CareLink Monitor Model 2490C, CareLink Express Monitor 2020B, CardioSight Reader Model 2020A, MyCareLink Monitor Model 24950 and Device Data Management Application (DDMA) Model 2491 to provide patient and device data transfer from the Evera MRI devices.
P920047/S084
9/15/15
Special
Maestro 3000 Cardiac Ablation System
Boston Scientific Corporation
San Jose, CA
95134
Approval for labeling modifications in compliance with electrical and EMC consensus standards.
P930014/S082
9/18/15
180-Day
Acrysof® Toric IOL & Acrysof® IQ Toric IOL
Alcon Research, Ltd.
Ft. Worth, TX 76134
Approval of the post-approval study protocol.
P930014/S084
9/29/15
Real-Time
AcrySof® IQ Aspheric Intraocular lens with UltraSert™ Preloaded Delivery System
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Approval to modify the AcrySert C Delivery System by reducing the size of the nozzle tip, adding an external nozzle tip depth guard, and adding a plunger spring and plunger lock, The device, as modified, will be marketed under the trade name AcrySof IQ Aspheric Intraocular lens with UltraSert Preloaded Delivery System. The AcrySof IQ posterior chamber intraocular lenses are indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. The lens is intended for placement in the capsular bag.
P930038/S078
9/30/15
Special
Angio-Seal Vascular Closure Device
St. Jude Medical, Inc.
Plymouth, MN 55442
Approval for implementation of a suture knot test inspection.
P930039/S138
9/11/15
180-Day
CapSureFix Novus SureScan Leads
Medtronic, Inc.
Mounds View, MN 55112
Approval of the Evera MRI XT/S DR and VR Implantable Cardioverter Defibrillator devices and programmer application software Model SW033 as well as extension of MR Conditional labeling and use for Sprint Quattro Secure lead Models 6935M and 6947M as MRI SureScan labeled 55 and 62cm leads. In addition to the system components listed, the use of the CapSureFix MRI SureScan Lead Model 5086MRI and CapSureFix Novus MRI SureScan Lead Model 5076 with the Evera MRI DR (dual chamber) system when an atrial pace/sense lead is indicated. Furthermore, you requested approval to use CareLink Monitor Model 2490C, CareLink Express Monitor 2020B, CardioSight Reader Model 2020A, MyCareLink Monitor Model 24950 and Device Data Management Application (DDMA) Model 2491 to provide patient and device data transfer from the Evera MRI devices.
P950029/S102
9/16/15
180-Day
Reply SR, Reply DR, Esprit SR, Esprit DR
Sorin Group- CRM
Arvada, CO
80004
Approval for the SMARTVIEW Hotspot Remote Monitoring System.
P960040/S351
9/17/15
Real-Time
TELIGEN ICD, INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, DYNAGEN EL ICD, DYNAGEN MINI, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD
Boston Scientific Corporation
St. Paul, MN
55112
Approval for modifications to pulse generator firmware and programmer software, for labeling changes associated with the software updates, and for the combination of physician technical manuals and device reference guides into one comprehensive document across device families.
P960058/S111
9/2/15
180-Day
HiResolution Bionic Ear System
Advanced Bionics LLC
Valencia, CA
91355
Approval for a new hybrid printed circuit board assembly (PCBA) for the HiRes 90K family of cochlear implants.
P980003/S063
9/15/15
Special
Maestro 3000 Cardiac Ablation System
Boston Scientific Corporation
San Jose, CA
95134
Approval for labeling modifications in compliance with electrical and EMC consensus standards.
P980016/S536
9/11/15
180-Day
Event MRI XT DR SureScan Evera MRI XT VR SureScan, Evera MRI S DR SureScan, and Evera MRI S VR
SureScan Implantable Cardioverter Defibrillators; Programmer
Software Model SW033
Medtronic, Inc.
Mounds View, MN 55112
Approval of the Evera MRI XT/S DR and VR Implantable Cardioverter Defibrillator devices and programmer application software Model SW033 as well as extension of MR Conditional labeling and use for Sprint Quattro Secure lead Models 6935M and 6947M as MRI SureScan labeled 55 and 62cm leads. In addition to the system components listed, the use of the CapSureFix MRI SureScan Lead Model 5086MRI and CapSureFix Novus MRI SureScan Lead Model 5076 with the Evera MRI DR (dual chamber) system when an atrial pace/sense lead is indicated. Furthermore, you requested approval to use CareLink Monitor Model 2490C, CareLink Express Monitor 2020B, CardioSight Reader Model 2020A, MyCareLink Monitor Model 24950 and Device Data Management Application (DDMA) Model 2491 to provide patient and device data transfer from the Evera MRI devices.
P980049/S105
9/16/15
180-Day
SMARTVIEW Remote Monitoring System
Sorin Group- CRM
Arvada, CO
80004
Approval for the SMARTVIEW Hotspot Remote Monitoring System.
P990071/S032
9/16/15
Special
Smart Ablate System
Biosense Webster, Inc.
Diamond Bar, CA 9176
Approval for an updated foot pedal warning.
P000037/S040
9/15/15
135-Day
On-X Prosthetic Heart Valve Mr. Walt Moeller
On-X Life Technologies, Inc.
Austin, TX
78752
Approval to add a second vacuum-assisted steam sterilizer.
P010012/S395
9/17/15
Real-Time
COGNIS CRT-D, INCEPTA CRT-D, ENERGEN CRT-D, PUNCTUA CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-, INOGEN CRT-, INOGEN X4 CRT-), ORIGEN CRT-D, ORIGEN X4 CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Approval for modifications to pulse generator firmware and programmer software, for labeling changes associated with the software updates, and for the combination of physician technical manuals and device reference guides into one comprehensive document across device families.
P020025/S078
9/15/15
Special
Maestro 3000 Cardiac Ablation System
Boston Scientific Corporation
San Jose, CA
95134
Approval for labeling modifications in compliance with electrical and EMC consensus standards.
P020045/S067
9/28/15
Real-Time
Cryoablation System
Medtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Approval for printed circuit board design and associated labeling changes for the Auto Connection Box and ECG Cable.
P030017/S229
9/18/15
Real-Time
Precision Spinal Cord Stimulator (SCS) System
Boston Scientific Corporation
Valencia, CA
91355
Approval for an alternate qualified supplier (resulting in a minor design change) for the coil connector component of the Precision SCS System.
P030017/S230
9/22/15
180-Day
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems
Boston Scientific Corporation
Valencia, CA
91355
Approval for a new lead anchor configuration. The device, as modified, will be marketed under the trade name Clik X Anchor and is indicated for use as an anchor for spinal cord stimulator leads.
P030022/S032
9/25/15
Real-Time
Reflection Ceramic Acetabular Hip System
Smith & Nephew, Incorporated
Cordova, TN
38016
Approval for an inner lid packaging change to BIOLOX FORTE Ceramic Heads.
P030035/S136
9/16/15
Real-Time
Anthem, Allure/RF, and Allure Quadra/RF family of CRT-Ps
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for updates to the Merlin@home EX2000 v8.1.1 Software for Models EX1150, EX1150W, EX1100, and EX1100W Transmitters.
P030054/S287
9/16/15
Real-Time
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify, Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+HF, and Atlas+HF/II HH/II+ HF family of
CRT-Ds
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for updates to the Merlin@home EX2000 v8.1.1 Software for Models EX1150, EX1150W, EX1100, and EX1100W Transmitters.
P040024/S082
9/24/15
Special
Restylane Silk
Galderma Laboratories L.P.
Fort Worth, TX 76177
Approval for changes in product labeling that included new safety information.
P050047/S044
9/30/15
Panel-Track
Juvéderm Ultra XC
Allergan
Irvine, CA
92612
Approval for the Juvéderm Ultra XC. This device is indicated for: 1) JUVÉDERM Ultra XC injectable gel is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds); and 2) JUVÉDERM Ultra XC is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
P050047/S050
9/30/15
Special
Juvéderm Hyaluronate Gel Implants
Allergan
Irvine, CA
92623
Approval for revised labeling to include FDA’s suggested verbiage, verbatim, to enhance the information provided to patients and physicians about the risks associated with vascular injection.
P050052/S070
9/2/15
180-Day
Radiesse® Dermal Filler
Merz North America, Inc.
Raleigh, NC
27615
Approval of the post-approval study protocol.
P060027/S072
9/16/15
180-Day
SMARTVIEW Remote Monitoring System
Sorin Group- CRM
Arvada, CO
80004
Approval for the SMARTVIEW Hotspot Remote Monitoring System.
P070015/S128
9/23/15
Panel-Track
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System
Abbott Vascular
Santa Clara, CA 95054
Approval for the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System, XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System and XIENCE Alpine Everolimus Eluting Coronary Stent System. These devices are indicated for the following: XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System. The XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V stent) is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. Additionally, the XIENCE V stent is indicated for treating de novo chronic total coronary occlusions. XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System The XIENCE PRIME stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. Additionally, the XIENCE PRIME stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System The XIENCE Xpedition stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Xpedition stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Alpine Everolimus Eluting Coronary Stent System, The XIENCE Alpine stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions.
P080012/S029
9/1/15
Real-Time
Prometra Programmable Implantable Pump
Flowonix Medical, Inc.
Mount Olive, NJ 07828
Approval for version 1.02.1 of the Prometra touchscreen programmer software.
P090013/S200
9/11/15
180-Day
MRI CapSureFix MRI SureScan Leads
Medtronic, Inc.
Mounds View, MN 55112
Approval of the Evera MRI XT/S DR and VR Implantable Cardioverter Defibrillator devices and programmer application software Model SW033 as well as extension of MR Conditional labeling and use for Sprint Quattro Secure lead Models 6935M and 6947M as MRI SureScan labeled 55 and 62cm leads. In addition to the system components listed, the use of the CapSureFix MRI SureScan Lead Model 5086MRI and CapSureFix Novus MRI SureScan Lead Model 5076 with the Evera MRI DR (dual chamber) system when an atrial pace/sense lead is indicated. Furthermore, you requested approval to use CareLink Monitor Model 2490C, CareLink Express Monitor 2020B, CardioSight Reader Model 2020A, MyCareLink Monitor Model 24950 and Device Data Management Application (DDMA) Model 2491 to provide patient and device data transfer from the Evera MRI devices.
P100026/S032
9/9/15
135-Day
Neuropace RNS System
NeuroPace, Inc.
Mountain View, CA 94043
Approval for an additional drying oven.
P100047/S046
9/25/15
180-Day
Heartware Ventricular Assist System
Heartware, Inc.
Miami, FL
33014
Approval of the post-approval study protocol.
P110011/S009
9/9/15
135-Day
Assurant Cobalt Iliac Balloon-Expandable Stent System
Medtronic Inc.
Santa Rosa, CA 95403
Approval for a change to in-process testing procedures.
P110019/S075
9/23/15
Panel-Track
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System, and XIENCE Alpine Everolimus Eluting Coronary Stent System
Abbott Vascular
Santa Clara, CA 95054
Approval for the XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System, XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System and XIENCE Alpine Everolimus Eluting Coronary Stent System. These devices are indicated for the following: XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System. The XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V stent) is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length <28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. Additionally, the XIENCE V stent is indicated for treating de novo chronic total coronary occlusions. XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System The XIENCE PRIME stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length < 32 mm) with reference vessel diameters of > 2.25 mm to <4.25 mm. Additionally, the XIENCE PRIME stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System. The XIENCE Xpedition stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Xpedition stent system is indicated for treating de novo chronic total coronary occlusions. XIENCE Alpine Everolimus Eluting Coronary Stent System, The XIENCE Alpine stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Alpine stent system is indicated for treating de novo chronic total coronary occlusions.
P110032/S011
9/1/15
Real-Time
Aorfix AAA Flexible Stent Graft System with Aorfix Delivery Device
Lombard Medical Technologies Inc.
Irvine, CA
92618
Approval for a change to the center tube of the delivery system.
P110033/S019
9/30/15
Special
Juvéderm Voluma XC
Allergan
Irvine, CA
92623
Approval for revised labeling to include FDA’s suggested verbiage, verbatim, to enhance the information provided to patients and physicians about the risks associated with vascular injection.
P120005/S037
9/23/15
Real-Time
Dexcom G4 Platinum Continuous Glucose Monitoring System
Dexcom, Inc.
San Diego, CA 92121
Approval for the following firmware modifications to the Share Receiver of the G4 PLATINUM Continuous Glucose Monitoring System: updates to prevent unnecessary reboots, improvements of speed of USB transfers, prevention of long charge times, improvement of connection reliability, improvement of battery life, improvement of button usability, and improvement of upgrade process.
P120010/S071
9/18/15
180-Day
MiniMed 530G System
Medtronic MiniMed
Northridge, CA 91325
Approval of the post-approval study protocol.
P120016/S014
9/30/15
180-Day
VASCADE 5F and 6/7F VCS, Vascular Closure System, Models: 700-5801 and 700-500DX
Cardiva Medical, Incorporated
Sunnyvale, CA 94085
Approval for a manufacturing site located at Cardiva Medical, Inc., Sonora, Mexico.
P130007/S005
9/24/15
Real-Time
Animas® Vibe™ System
Animas Corporation
West Chester, PA 19380
Approval for modifications to the materials used in the flexible copper circuit for the printed circuit board assembly used with the Animas Vibe Insulin Pump, a component of the Animas Vibe System.
P130009/S038
9/2/15
Real-Time
Ascendra+ Delivery System
Edwards Lifesciences, LLC.
Irvine, CA
92614
Approval to supply the stopcock unattached from the Ascendra+ Delivery System.
P130013/S005
9/2/15
Special
Watchman LAA Closure Technology
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for changes to the labeling to clarify use of the hemostasis valve on the WATCHMAN Access System.
P130017/S004
9/25/15
180-Day
Cologuard
Exact Sciences, Inc.
Madison, WI
53719
Approval of the post-approval study protocol.
P130024/S007
9/4/15
Special
Lutonix 035 Drug Coated Balloon PTA Catheter
Lutonix, Inc.
New Hope, MN 55428
Approval for clarification changes to the IFU to include communication of best practices to enhance the safe use of the device.
P130026/S008
9/3/15
Real-Time
TactiCath Quartz Ablation Catheter
St. Jude Medical
Plymouth, MN 55442
Approval to update the design and inspection location for the spine component of the TactiCath Ablation catheter.
P140028/S001
9/21/15
180-Day
Innova Vascular Self-Expanding Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for 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
P840001/S310
9/4/15
Restore, Itrel and Synergy Spinal Cord Stimulation Systems and Pisces, Resume, Specify, and Vectris Spinal Cord Stimulation Leads
Medtronic Inc.
Minneapolis, MN
55432
A new hard stop and upper arm implementation for the crimpers used during the sleeve to wire assembly of the spinal cord stimulation leads.
P850022/S025
9/9/15
Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator
Ebi, LLC.
Parsippany, NJ 07054
Qualify two alternate suppliers for the Soft-Touch® Hydrogel disposable, cutaneous electrodes and to reinstate the Soft-Touch® 63B hydrogel based, disposable, cutaneous electrode used in conjunction with the Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and SpinalPak® Non-invasive Spine Fusion Stimulator System.
P880086/S259
9/3/15
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, Verity ADx
St. Jude Medical
Sylmar, CA
91342
Use of an automated environment monitoring system to replace existing manual chart recorders.
P910001/S080
9/30/15
ELCA Coronary Laser Atherectomy Catheters
Spectranetics, Inc.
Colorado Springs, CO
80921
Change to optical fiber manufacturing process.
P910023/S359
9/3/14
Current+, Fortify Assura, Ellipse, Merlin.net (Merlin.net system), Merlin@Home (EX2000, EX1150, EX1100)
St. Jude Medical
Sylmar, CA
91342
Use of an automated environment monitoring system to replace existing manual chart recorders.
P910023/S360
9/10/15
Fortify DR, Fortify VR, Fortify Assura DR, Fortify Assura VR
St. Jude Medical
Sylmar, CA
91342
Alternate supplier of the DF-1 connectors for the devices.
P930029/S053
9/2/15
RF Contactr, RF Enhancr II, RF Marinr, RF Conductr
Medtronic, Inc.
Mounds View, MN 55112
Implementation of an automatic cutting machine and an associated inspection fixture.
P950022/S088
9/3/15
Durata, Optisure
St. Jude Medical
Sylmar, CA
91342
Use of an automated environment monitoring system to replace existing manual chart recorders.
P960004/S073
9/23/15
Fineline II Sterox Endocardial Pacing Leads, Fineline II Sterox EZ Endocardial Pacing Leads
Boston Scientific Corporation
St. Paul, MN
55112
Changes to the laser welding process and inspections of the resulting weld.
P960013/S077
9/3/15
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead
St. Jude Medical
Sylmar, CA
91342
Use of an automated environment monitoring system to replace existing manual chart recorders.
P960030/S039
9/3/15
IsoFlex Optim
St. Jude Medical
Sylmar, CA
91342
Use of an automated environment monitoring system to replace existing manual chart recorders.
P960058/S118
9/18/15
HiResolution Bionic Ear System
Advanced Bionics, LLC
Valencia, CA
91355
Change in location of the supplier of raw polyethylene material used to manufacture braided fiber that is then used in the HiRes 90KTM Advantage antenna coil, and expanded material specifications for both the raw fiber and the braided fiber.
P970003/S185
9/30/15
Pulse/Pulse Duo Generator, Demipulse/ Demipulse Duo Generator, AspireHC Generator, AspireSR Generator
Cyberonics, Inc.
James Shene
Houston, TX
77058
Implementation of an alternate spot welding system used during manufacture of the VNS Therapy System.
P970004/S203
9/9/15
InterStim Therapy System for Urinary Control
Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing change to expand the upper limit of the temperature range for the conditioning phase of the standard sterilization cycle at the Medtronic Neuromodulation Sullivan Lake and Rice Creek manufacturing facilities.
P970013/S065
9/3/15
Microny
St. Jude Medical
Sylmar, CA
91342
Use of an automated environment monitoring system to replace existing manual chart recorders.
P980016/S546
9/9/15
Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDs
Medtronic, Inc.
Mounds View, MN 55112
New continuous monitoring system for the manufacturing area at a final device manufacturing facility.
P980018/S020
9/10/15
HercepTest™
Dako Denmark A/S
Glostrup, Denmark
DK-2600
Alternate warehouse established within the current facility. The change is being made for the storage of finished devices after they have been QA released.
P980035/S434
9/2/15
Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Use of an existing alternate manufacturing line to manufacture the devices.
P980035/S435
9/9/15
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Advisa SR MRI, and Relia IPGs
Medtronic, Inc.
Mounds View, MN 55112
New continuous monitoring system for the manufacturing area at a final device manufacturing facility.
P980035/S436
9/10/15
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Updates to the battery H2 cathode mix process.
P980035/S438
9/29/15
Advisa DR IPG,
Advisa DR MRI IPG, Advisa SR MRI IPG
Medtronic, Inc.
Mounds View, MN 55112
Use of a new infrared cure oven.
P980037/S047
9/17/15
Angiojet Ultra Thrombectomy System Console
Boston Scientific Corporation
Marlborough, MA 01752
Change to the console manufacturing process.
P980037/S048
9/21/15
Angiojet Ultra Thrombectomy System Console
Boston Scientific Corporation
Marlborough, MA 01752
Change to the component cleaning process.
P990040/S021
9/25/15
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
Codman & Shurtleff, Inc.
Raynham, MA 02767
Removal of the incoming inspection requirement for performing material identification via Fourier Transform Infrared Spectroscopy (FTIR) testing on the n-BCA self-piercing caps; and Reduce the sampling requirement for the visual appearance inspection of the n-BCA.
P990081/S032
9/11/15
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc.
Tuscon, AZ
85755
Addition of a new supplier of a Nozzle Plate used in the production of the BenchMark ULTRA instrument, which is part of the PMA system for the reagents.
P990081/S033
9/24/15
PATHWAY Anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody
Ventana Medical Systems, Inc. Tucson, AZ
85755
Change from manual kitting to automated kitting of the reagent dispensers.
P000014/S031
9/8/15
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent
Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrators
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Change to an environmentally controlled room used for dispensing VITROS reagents.
P000044/S032
9/8/15
VITROS Immunodiagnostic Products HBsAg Reagent Pack, VITROS Immunodiagnostic Products HBsAg Confirmatory Kit, and VITROS Immunodiagnostic Products HBsAg Calibrator
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Change to an environmentally controlled room used for dispensing VITROS reagents.
P010003/S019
9/24/15
Bioglue Surgical Adhesive
Cryolife, Inc.
Kennesaw, GA 30144
Change in the method to determine protein concentration.
P010015/S277
9/9/15
Consulta, Syncra, and Viva CRT-Ps
Medtronic, Inc.
Mounds View, MN 55112
New continuous monitoring system for the manufacturing area at a final device manufacturing facility.
P010015/S278
9/10/15
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Updates to the battery H2 cathode mix process.
P010021/S027
9/8/15
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and VITROS Immunodiagnostic Products Anti-HCV Calibrator
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Change to an environmentally controlled room used for dispensing VITROS reagents.
P010031/S509
9/9/15
Brava, Brava Quad, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva Quad S, Viva Quad XT, Viva S, Viva XT CRT-Ds
Medtronic, Inc.
Mounds View, MN 55112
New continuous monitoring system for the manufacturing area at a final device manufacturing facility.
P010032/S099
9/10/15
Genesis and Eon Family Spinal Cord Stimulation (SCS) System
St. Jude Medical
Plano, TX
75024
Acceptance of replacing an existing centerless grinder (Glebar TF-9DHD) with a new centerless grinder (Glebar GT-9DHD) used during the manufacturing of SCS leads, DBS leads, and terminal end subassemblies.
P020004/S121
9/21/15
GORE EXCLUDER AAA Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Optional use of an alternate method to loosen the graft from the processing mandrel.
P020004/S122
9/23/14
GORE EXCLUDER AAA Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Relocation of the processes and equipment for the Excluder SIM-PULL System Catheter manufacturing line from Flagstaff, Arizona to Phoenix, Arizona.
P020055/S017
9/24/15
PATHWAY anti-c-KIT (9.7) Primary Antibody
Ventana Medical Systems, Inc. Tucson, AZ
85755
Change from manual kitting to automated kitting of the reagent dispensers.
P030009/S082
9/18/15
Integrity Coronary Stent System
Medtronic, Inc.
Santa Rosa, CA 95403
Change to the catheter subassembly manufacturing process.
P030017/S232
9/2/15
Precision Spectra Spinal Cord Stimulator System
Boston Scientific Corporation
Valencia, CA
91355
Use of a new incubator (Boekel Model 138225) in the curing process for the header of the Precision Spectra implanted pulse generator.
P030017/S233
9/10/15
Precision Spectra Spinal Cord Stimulator (SCS) System
Boston Scientific Corporation
Valencia, CA
91355
Acceptance of alternate laser marking equipment used in the Case Half etching process during the manufacturing of the Precision Spectra Implantable Pulse Generator (IPG).
P030024/S023
9/8/15
VITROS Immunodiagnostics Products Anti-HBc Reagent Pack and VITROS Immunodiagnostics Products Anti-HBc Calibrator
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Change to an environmentally controlled room used for dispensing VITROS reagents.
P030026/S030
9/8/15
VITROS Immunodiagnostics Products Anti-HBc IgM Reagent Pack and VITROS Immunodiagnostics Products Anti-HBc IgM Calibrator
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Change to an environmentally controlled room used for dispensing VITROS reagents.
P030035/S137
9/3/15
Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF Family of CRT-P Devices
St. Jude Medical
Sylmar, CA
91342
Use of an automated environment monitoring system to replace existing manual chart recorders.
P030053/S030
9/24/15
Mentor Memory Gel Silicone Gel-Filled Breast Implants
Mentor Worldwide LLC
Somerville, NJ 08876
Change the sample size for in-process silicone gel penetration testing.
P030054/S288
9/3/15
Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, QuickFlex μ, Quartet, Merlin Programmer
St. Jude Medical
Sylmar, CA
91342
Use of an automated environment monitoring system to replace existing manual chart recorders.
P030054/S289
9/10/15
Quadra Assura, Unify, Unify Assura, Unify Quadra
St. Jude Medical
Sylmar, CA
91342
Alternate supplier of the DF-1 connectors for the devices.
P040005/S011
9/10/15
HER2 IQFISH pharmDx™
Dako Denmark A/S
Glostrup, Denmark
DK-2600
Alternate warehouse established within the current facility. The change is being made for the storage of finished devices after they have been QA released.
P040024/S084
9/25/15
Restylane, Restylane-L, Perlane, Restylane Lyft, and Restylane Silk
Galderma Laboratories, L.P. Fort Worth, TX 76177
Rebuilding airlocks within the Restylane, Restylane-L, Perlane, Restylane Silk, and Restylane Lyft manufacturing facility.
P040024/S085
9/25/15
Restylane, Restylane-L, Perlane, Perlane-1, Restylane Silk
Galderma Laboratories, L.P. Fort Worth, TX 76177
Rebuilding of the media systems within the Restylane, Restylane-L, Perlane, Restylane Silk, and Restylane Lyft manufacturing facility.
P040043/S076
9/4/15
Conformable Gore Tag Thoracic Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Implementation of an Optic Measuring and Laser Cutting Machine.
P040043/S077
9/10/15
Gore Conformable TAG Thoracic Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Use of an alternate PTFE resin in the sealing cuff and graft components.
P050006/S048
9/1/15
Gore Cardioform Septal Occluder
W.L. Gore & Associates, Inc
Phoenix, AZ
85085
Replace the oven used to create the leaflet bag component of the Gore Cardioform Septal Occluder.
P050038/S026
9/9/15
Arista AH, Arista AH Flexitip/Flexitip XL/Flexitip XL-R
C.R. Bard Incorporated
Woburn, MA
01801
Changes in the manufacturing process of the Arista AH FlexiTip XL-R stainless steel component.
P060006/S069
9/2/15
Express™ SD Renal Pre-mounted Stent System
Boston Scientific
Maple Grove, MN 55311
Manufacturing change to the sealing process of Poly-Poly header bags.
P060011/S008
9/9/15
Rayner C-flex,
C-flex Aspheric, and Aspheric Intraocular Lenses
Rayner Intraocular Lenses Ltd.
East Sussex,
United Kingdom
BN3 7AN
Change in the blister tray and foil lid material specification.
P060037/S039
9/11/15
Zimmer NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee
Zimmer, Incorporated
Shannon, Co Clare
Ireland
Change in the PMMA process specification.
P080025/S098
9/9/15
InterStim Therapy System for Bowel Control
Medtronic Neuromodulation
Minneapolis, MN 55432
Manufacturing change to expand the upper limit of the temperature range for the conditioning phase of the standard sterilization cycle at the Medtronic Neuromodulation Sullivan Lake and Rice Creek manufacturing facilities.
P090013/S196
9/9/15
Revo MRI SureScan IPG
Medtronic, Inc.
Mounds View, MN 55112
New continuous monitoring system for the manufacturing area at a final device manufacturing facility.
P090013/S197
9/10/15
Revo MRI SureScan IPG
Medtronic, Inc.
Mounds View, MN 55112
Updates to the battery H2 cathode mix process.
P090028/S009
9/8/15
VITROS Immunodiagnostic Products HBeAg Reagent Pack, VITROS Immunodiagnostic Products HBeAg Calibrator, and VITROS Immunodiagnostic Products HBeAg Controls
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Change to an environmentally controlled room used for dispensing VITROS reagents.
P100001/S008
9/8/15
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, and VITROS Immunodiagnostic Products Anti-HBe Controls
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Change to an environmentally controlled room used for dispensing VITROS reagents.
P100021/S049
9/11/15
Endurant, Endurant II, and Endurant IIs Stent Graft Systems
Medtronic Inc.
Santa Rosa, CA 95403
Introduction of a manufacturing aid during the delivery system external handle assembly process.
P100023/S122
9/29/15
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Change to the secondary packaging process
P100024/S007
9/10/15
HER2 CISH pharmDx™ Kit
Dako Denmark A/S
Glostrup, Denmark
DK-2600
Alternate warehouse established within the current facility. The change is being made for the storage of finished devices after they have been QA released.
P100027/S022
9/11/15
INFORM HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc.
Tuscon, AZ
85755
Addition of a new supplier of a Nozzle Plate used in the production of the BenchMark ULTRA instrument, which is part of the PMA system for the aforementioned reagents.
P100027/S023
9/24/15
INFORM HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc.
Tucson, AZ
85755
Change from manual kitting to automated kitting of the reagent dispensers.
P100029/S020
9/22/15
Trifecta Valve
St. Jude Medical, Inc.
Plymouth, MN 55442
Change to tissue stitching specifications.
P100033/S006
Progensa® PCA3 Assay
Hologic, Inc.
San Diego, CA 92121
Change in supplier for the magnetic particles (CH0206) used in the manufacture of the Progensa® PCA3 assay from Thermo Fisher Scientific to GE Healthcare.
P100040/S024
9/11/15
Valiant Thoracic Stent Graft with the Captivia Delivery System
Medtronic Inc.
Santa Rosa, CA 95403
Introduction of a manufacturing aid during the delivery system external handle assembly process and an associated modification to the packaging tray.
P110004/S012
9/3/15
NIRxcell CoCr Coronary Stent on Rx System
Medinol Ltd.
Tel-Aviv, Israel
61581
Change to decrease the crimping and pre-crimping forces in the 3.5x 24mm and 4.0 x 08mm stent sizes.
P110010/S115
9/3/15
Promus PREMIER Everolimus-Eluting Platinum Chromium
Coronary Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Change to the environmental monitoring data collection process.
P110013/S055
9/18/15
Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Medtronic, Inc.
Santa Rosa, CA 95403
Change to the catheter subassembly manufacturing process.
P110013/S056
9/17/15
Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems
Medtronic, Inc.
Santa Rosa, CA 95403
Changes to the controlled environment processing.
P110013/S057
9/29/15
Resolute Integrity Zotarolimus Eluting Coronary Stent Systems
Medtronic, Inc.
Santa Rosa, CA 95403
Change to the inspection process for the Resolute Integrity device.
P110016/S020
9/2/15
Therapy Cool Flex and FlexAbility Ablation Catheters
Irvine Biomedical, Inc.
Plymouth, MN 55442
Final cleaning solution change.
P110016/S022
9/14/15
FlexAbility Ablation Catheters (Uni-Directional and Bi-Directional)
St. Jude Medical
Plymouth, MN 55442
Reduction in bacterial endotoxin testing frequency for the FlexAbility Ablation Catheters manufactured in Plymouth, Minnesota.
P110035/S033
9/25/15
Epic Vascular Self-Expanding Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Removal of the alkaline tank and subsequent rinse tank from the electropolishing process.
P130013/S003
9/3/15
WATCHMAN Left Atrial Appendage Closure Technology
Boston Scientific Corporation
Maple Grove, MN 55311
Change to the environmental monitoring data collection process.
P130030/S016
9/2/15
REBEL™ Monorail™ and Over-the-Wire Platinum Chromium
Coronary Stent System
Boston Scientific
Maple Grove, MN 55311
Manufacturing change to the sealing process of Poly-Poly header bags.
P140009/S003
9/10/15
Brio Neurostimulation System
St. Jude Medical
Plano, TX
75024
Replacing an existing centerless grinder (Glebar TF-9DHD) with a new centerless grinder (Glebar GT-9DHD) used during the manufacturing of SCS leads, DBS leads, and terminal end subassemblies.
P140023/S002
9/24/15
cobas® KRAS Mutation Test
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
GE Healthcare sourced material manufactured at the ThermoFisher Scientific facility located in Vilnius, Lithuania as an approved supplier of polyadenylic acid polymer, potassium salt (poly A) for the Roche Molecular Systems facility in Branchburg, New Jersey.
P140025/S001
9/24/15
Ventana ALK (D5F3) CDx Assay
Ventana Medical Systems, Inc.
Tucson, AZ
85755
Change from manual kitting to automated kitting of the reagent dispensers.
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