The Food & Drug Administration today released a list of pre-market approvals granted in December 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 81
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 599
Total Active: 423
Total On Hold: 176
Summary of All PMA Submissions
Originals: 3
Supplements: 92
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 81
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 163.1
FDA Time: 140.4 Days
MFR Time: 22.7 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P140030
12/17/15
Astron Peripheral Self-Expanding Nitinol Stent System
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the Astron Peripheral Self-Expanding Stent System. This device is indicated for improving luminal diameter in patients with iliac atherosclerotic lesions in vessel reference diameters between 4.3mm and 9.5mm and lesion lengths up to 105mm.
P150019
12/7/15
Paradigm Real-Time Revel System
Medtronic MiniMed
Northridge, CA 91325
Approval for the Paradigm Real-Time Revel System. This device is indicated for: Paradigm REAL-Time Revel insulin pump. The Paradigm REAL-Time Revel insulin pumps (MMT-523/MMT-723) are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Paradigm REAL-Time Revel system consists of the Paradigm MMT-523/MMT-723 insulin pumps, the Enlite glucose sensor (MMT-7008), and the MiniLink Transmitter (MMT-7703). Use of the Paradigm MMT-523/MMT-723 insulin pumps with the optional sensor and transmitter components is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older). Enlite Sensor: The Enlite sensor (MMT-7008) is intended for use with the Paradigm REAL-Time Revel insulin pump systems (MMT-523/MMT-723) to continuously monitor glucose levels in persons with diabetes. Glucose values provided by the Paradigm REAL-Time Revel system are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the sensor glucose readings provided by the Paradigm REAL-Time Revel system.
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL
DEVICE TRADE NAME
COMPANY NAME CITY, STATE, & ZIP
DEVICE DESCRIPTION / INDICATIONS
P810031/S055
12/22/15
Special
Sodium Hyaluronate Ophthalmic Viscoelastic Devices- Healon®, Healon GV®, Healon5® Products, Healon® Ultimate Dual Pack, and Healon Duet® Dual Pack
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Approval for changes made to the Directions for Use (DFU).
P840001/S312
12/21/15
135-Day
Itrel and Restore SCS Systems
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P850064/S028
12/17/15
180-Day
Life Pulse High Frequency Ventilator
Bunnell, Inc.
Salt Lake City, UT 84115
Approval to upgrade the Life Pulse High Life Pulse High Frequency Ventilator 204 and patient box 213.
P860004/S235
12/30/15
135-Day
SynchroMed® II Pumps
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the propellant test method and process control limits used during manufacturing of the SynchroMed II pump.
P860004/S236
12/21/15
135-Day
SynchroMed Infusion System
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P880086/S262
12/6/15
Real-Time
Assurity, Assurity+, Endurity, Accent Family of Pacemakers
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for the Merlin.net MN5000 Version 7.3 Software.
P890003/S341
12/8/15
Real-Time
MyCareLink Patient Monitor
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P890003/S342
12/8/15
Real-Time
MyCareLink Patient Monitor
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P910023/S364
12/6/15
Real-Time
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for the Merlin.net MN5000 Version 7.3 Software.
P930014/S085
12/4/15
Real-Time
Alcon Online Toric IOL Calculator for the Acrysof ® Toric and IQ Toric Intraocular Lenses (IOLs)
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Approval for the Alcon Online Toric IOL Calculator which is a modification of the Toric IOL Calculators. The device, as modified, will be marketed under the trade name Alcon Online Toric IOL Calculator for the Acrysof Toric and IQ Toric IOLs. The ACRYSOF Toric and IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
P950005/S051
12/17/15
180-Day
Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ Steer DS Catheter
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a manufacturing site located at Sterigenics, in Los Angeles, California as an alternate sterilization site.
P950037/S151
12/21/15
180-Day
Setrox S 53 and Safio S 53 Drug Eluting Permanent Right Ventricular or Right Atrial Pacemaker Electrodes
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ProMRI Full Body Scan ICD System.
P960009/S237
12/21/15
135- Day
Activa DBS System
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P960040/S360
12/21/15
180-Day
DYNAGEN EL ICD, INOGEN EL ICD, ORIGEN EL ICD, DYNAGEN MINI, INOGEN MINI, ORIGEN MINI ICD
Boston Scientific
St. Paul, MN
55112
Approval for hardware modifications to the NG3 family of devices.
P960043/S091
12/31/15
180-Day
Prostar XL Percutaneous Vascular Surgical System
Abbott Vascular
Temcula, CA
92591
Approval for manufacturing sites located at Abbott Vascular, Inc., in Tipperary Ireland and Synergy Health Ireland Ltd., in Offaly Ireland.
P970003/S182
12/18/15
180-Day
VNS Therapy System-Aspire Generator
Cyberonics, Inc.
Houston, TX
77058
Approval for using a 2-position pre-surgical surface electrocardiograph (ECG) assessment procedure to identify implant location.
P970004/S204
12/21/15
135-Day
InterStim Therapy System
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P970029/S028
12/22/15
Special
CardioGenesis TMR System
CryoLife, Inc.
Kennesaw, GA 30144
Approval of updates regarding foreign material inspections, and leak testing.
P970051/S130
12/4/15
135-Day
Nucleus 24 Cochlear Implant System
Cochlear Americas
Centennial, CO 80111
Approval for the addition of an alternative automated electrode pad cleaning method using laser ablation.
P980016/S556
12/8/15
Real-Time
Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P980016/S558
12/08/15
Real-Time
Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Intrinsic 30 ICD, Marquis VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P980023/S072
12/21/15
180-Day
Linox S Drug Eluting Permanent Defibrillator Electrodes. Protego DF-1, Drug Eluting Permanent Defibrillator Electrodes
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ProMRI Full Body Scan ICD System.
P980025/S003
12/10/15
180-Day
Logicon Caries Detector
GA Industries
Rancho Palos Verdes, CA
90275
Approval for a manufacturing site located at Carestream Dental in Atlanta, Georgia.
P980035/S443
12/8/15
Real-Time
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, EnPulse E1/E2 IPG, Kappa D/DR/SR/VDD IPG
Medtronic, Inc.
Mounds View, MN 55112
pproval for firmware updates to the MyCareLink patient home monitor.
P980035/S446
12/8/15
Real-Time
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, EnPulse E1/E2 IPG, Kappa D/DR/SR/VDD IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P980037/S046
12/14/15
135-Day
AngioJet® Rheolytic™ Thrombectomy System
Boston Scientific Corporation
Minneapolis, MN 55433
Approval for an alternate vendor.
P980037/S053
12/11/15
180-Day
AngioJet® Rheolytic™ Thrombectomy Set
Boston Scientific Corporation
Maple Grove, MN, 55311
Approval for a manufacturing site located at Boston Scientific Corporation in Maple Grove, Minnesota.
P980044/S027
12/21/15
Panel-Track
VISCO-3™
Seikagaku Corporation
Tokoyo, Japan
100-0005
Approval for VISCO-3. This device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
P980046/S009
12/9/15
180-Day
Home Access® Hepatitis C CheckSM
Home Access Health Corporation
Hoffman Estates, IL 60169
Approval for 1) Removal of testing with the CHIRON® RIBA® HCV 3.0 SIA (RIBA) from the laboratory protocol; 2) Reporting of repeatedly reactive specimens as “Presumptive HCV Infection”; 3) Reporting of specimens for which antibodies to the hepatitis C virus were not found as “Negative”; 4) Home Access Hepatitis C Check had previously identified either Indeterminate or Positive as the reportable result; the communication will now be the same for both types of results, namely, Presumptive HCV Infection and for the patient to consult a physician of their choice and/or re-test by nucleic acid testing (NAT) for HCV RNA or equivalent; 5) Revision of the informational brochure “Answers to Frequently Asked Questions about Hepatitis C” to exclude reference to RIBA® as part of the laboratory protocol and to modify the definition of results to reflect Presumptive HCV Infection.
P990025/S040
12/17/15
180-Day
Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a manufacturing site located at Sterigenics, in Los Angeles, California as an alternate sterilization site.
P990071/S028
12/17/15
180-Day
RADIOFREQUENCY GENERATOR –CABLES
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a manufacturing site located at Sterigenics, in Los Angeles, CA as an alternate sterilization site.
P000009/S063
12/21/15
180-Day
ICS 3000/Renamic Programmers (Software 1503.U)
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ProMRI Full Body Scan ICD System.
P000014/S029
12/16/15
180-Day
VITROS® Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrators
Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Approval for removal of antifoam from a reagent and implementation of a new well wash protocol for the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrators.
P000021/S027
12/15/15
135-Day
Dimension TPSA Flex Reagent Cartridge and Dimension Vista TPSA Flex Reagent Cartridge
Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for the modified process of manufacturing the polypropylene resin used in the production of Dimension HM Reaction Vessels and the Vista LOCI Reaction Vessels.
P000025/S082
12/3/15
Real-Time
Combi 40+ Cochlear Implant System: Mi1200 SYNCRHONY Implant Magnet and Mi1200 Replacement Magnet
MED-EL Corporation
Durham, NC
27713
Approval for a change to the magnet material used to manufacture the Mi1200 SYNCHRONY magnet assemblies and the Mi1200 replacement magnets. The change is intended to replace the currently used magnet material which is discontinued by the supplier.
P000058/S059
12/4/15
180-Day
INFUSE® Bone Graft/Medtronic Interbody Fusion Device
Medtronic Sofamor Danek USA, Incorporated
Memphis, TN 38132
Approval for expansion of the approved indications for use of INFUSE Bone Graft to include implantation with two additional interbody fusion devices, the PERIMETER Interbody Fusion Device or the CLYDESDALE Spinal System, utilizing select open surgical procedures in conjunction with supplemental spinal fixation hardware. The device, as modified, will be marketed under the trade name INFUSE Bone Graft/ Medtronic Interbody Fusion Device and is indicated for: “spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or Grade 1 retrolisthesis at the involved level. Patients receiving the INFUSE Bone Graft/Medtronic Interbody Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the INFUSE Bone Graft/Medtronic Interbody Fusion Device. The following interbody devices and surgical approaches may be used with INFUSE Bone Graft: 1) The LT-CAGE Lumbar Tapered Fusion Device, implanted via an anterior open or an anterior laparoscopic approach at a single level; 2) The INTER FIX or INTER FIX RP Threaded Fusion Device, implanted via an anterior open approach at a single level; 3) The PERIMETER Interbody Fusion Device implanted via a retroperitoneal anterior lumbar interbody fusion (ALIF) at a single level from L2-S1or an oblique lateral interbody fusion (OLIF) approach at a single level from L5-S1; and 4) The CLYDESDALE Spinal System, implanted via an OLIF approach at a single level from L2-L5.”
P010012/S405
12/21/15
180-Day
DYNAGEN CRT-D, DYNAGEN X4 CRT-, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D
Boston Scientific
St. Paul, MN
55112
Approval for hardware modifications to the NG3 family of devices.
P010015/S283
12/8/15
Real-Time
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P010015/S285
12/8/15
Real-Time
Consulta CRT-P, Syncra CRT-P, Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P010030/S056
12/17/15
Panel-Track
LifeVest Wearable Cardioverter Defibrillators
ZOLL Manufacturing Corporation
Pittsburgh, PA 15238
Approval for the LifeVest Wearable Cardioverter Defibrillator, Models 3000, 3100, and 4000. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. The LifeVest system is indicated for patients under 18 years of age who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. Patients must have a chest circumference of 26 inches (66 centimeters) or greater and a weight of 18.75 kilograms (41.3 pounds) or greater.
P010031/S517
12/8/15
Real-Time
Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S/XT CRT-D, Viva S/XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P010031/S520
12/8/15
Real-Time
Brava CRT-D, Brava Quad CRT-D, Concerto ICD, Concerto II CRT-D, Consulta CRT-D, InSync II Protect ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S/XT CRT-D, Viva S/XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P010032/S102
12/18/15
Real-Time
Eon Charging System, Eon Mini LE Charging System, Prodigy Charging System
St. Jude Medical
Plano, TX
75024
Approval for modifying the internal switch mechanism of the IPG charging device.
P010068/S040
12/17/15
180-Day
Biosense Webster cables, Celsius DS Catheter, Celsius FLTR , EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT DS Catheter
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a manufacturing site located at Sterigenics, in Los Angeles, CA as an alternate sterilization site.
P020027/S022
12/15/15
135-Day
Dimension FPSA Flex Reagent Cartridge and Dimension Vista FPSA Flex Reagent Cartridge
Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for the modified process of manufacturing the polypropylene resin used in the production of Dimension HM Reaction Vessels and the Vista LOCI Reaction Vessels.
P020045/S069
12/31/15
Special
Freezor Cardiac Cryoablation Catheter, Freezor Xtra Surgical Catheter
Metronic Cryocath Lp
Quebec, CANADA
H9R5Z8
Approval for an additional 20X magnification inspection of the catheters’ shafts.
P030011/S036
12/9/15
Special
SynCardia temporary Total Artificial Heart (TAH-t) System – Companion 2 Driver System
SynCardia Systems, Inc.
Tucson, AZ
85713
Approval for the addition of two warnings to the Companion 2 Driver System Operator Manual.
P030031/S059
12/17/15
180-Day
Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Catheter, ThermoCool SF Catheters, ThermoCool SF NAV Catheters, ThermoCool SmarTouch Catheters
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a manufacturing site located at Sterigenics, in Los Angeles, CA as an alternate sterilization site.
P030035/S140
12/6/15
Real-Time
Anthem, Allure/RF, Allure Quadra/RF Family of CRT-Ps
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for the Merlin.net MN5000 Version 7.3 Software.
P030052/S017
12/29/15
135-Day
UroVysion™ Bladder Cancer Kit
Abbott Molecular, Inc.
Des Plaines, IL 60018
Approval for manufacturing process changes to components of the ProbeChek Control Slides for FISH using UroVysion Bladder Cancer Kit.
P030054/S294
12/6/15
Real-Time
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+HF, Atlas+HF/II HH/II+ HF Family of CRT-Ds
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for the Merlin.net MN5000 Version 7.3 Software.
P040024/S083
12/15/15
Real-Time
Restylane, Restylane-L, Perlane, Perlane-L, Restylane Silk
Galderma Laboratories L.P.
Fort Worth, TX 76177
Approval for a new supplier of raw Hyaluronic Acid (HTL Biotechnology S.A.S., France).
P040033/S024
12/11/15
180-Day
Birmingham Hip Resurfacing (BHR) System
Smith & Nephew Orthopaedics
Cordova, TN
38016
Approval for an update to the device labeling to include the results of the completed United Kingdom (UK) post-approval study.
P040036/S044
12/17/15
180-Day
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Catheter, ThermoCool SmarTouch Catheters
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for a manufacturing site located at Sterigenics, in Los Angeles, California as an alternate sterilization site.
P040044/S066
12/3/15
Real-Time
MynxGrip Vascular Closure Device
Access Closure, Inc.
Santa Clara, CA 95054
Approval for an extension of shelf life from one year to two years.
P050023/S087
12/21/15
180-Day
Iforia 7 DR-T, Iperia 7 DR-T, Inventra 7 DR-T and Iforia 7 VR-T DX Implantable Dual- Chamber Defibrillators. Iperia 7 VR-T DX and Inventra 7 VR-T DX Single Chamber Implantable Defibrillators
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ProMRI Full Body Scan ICD System.
P050023/S090
12/18/15
180-Day
CardioMessenger Smart
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for CardioMessenger Smart Model 401831.
P050037/S063
12/11/15
Special
Radiesse, Radiesse (+)
Merz North America, Inc
Franksville, WI 53126
Approval for changes in product labeling – update of adverse effects descriptions.
P050052/S074
12/11/15
Special
Radiesse, Radiesse (+)
Merz North America, Inc
Franksville, WI 53126
Approval for changes in product labeling – update of adverse effects descriptions.
P070008/S063
12/21/15
180-Day
ICS 3000/Renamic Programmers (Software 1503.U)
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the ProMRI Full Body Scan ICD System.
P080012/S031
12/28/15
180-Day
Prometra Programmable Infusion Pump System
Flowonix Medical, Inc.
Mt. Olive, NJ
07828
Approval of the following changes to the post-approval study for the device: a revision to allow for the use of the approved Patient Therapy Controller or PTC in the post-approval clinical study for the Prometra Implantable Programmable Pump System.
P080025/S099
12/21/15
135-Day
InterStim Therapy System
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes to the H2 cathode mix process used to manufacture batteries for implantable devices.
P080032/S016
12/29/15
180-Day
Alair Bronchial Thermoplasty System
Boston Scientific Corporation
Marlborough, MA 01752
Approval for design change to the Alair RF Controller to replace an obsolete component that is no longer commercially available.
P090013/S206
12/8/15
Real-Time
Revo MRI SureScan IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P090013/S207
12/8/15
Real-Time
Revo MRI SureScan IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval for firmware updates to the MyCareLink patient home monitor.
P090016/S018
12/11/15
Special
Belotero Balance
Merz North America, Inc.
Franksville, WI 53126
Approval for changes in product labeling- update to the post-market surveillance information, further clarification regarding adverse events and information regarding treatments to postmarket surveillance section
P100041/S065
12/7/15
135-Day
SAPIEN Transcatheter Heart Valve Crimper
Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for modifications to the cleaning process for small and large components at the Draper facility.
P110007/S007
12/22/15
Special
Healon® EndoCoat Ophthalmic Viscosurgical Devices (OVD), (3% Sodium Hyaluronate)
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Approval for changes made to the Directions for Use (DFU) to clarify instructions for use of the finger grip.
P110016/S026
12/11/15
Special
FlexAbility Ablation Catheter
St. Jude Medical, Inc.
St. Paul, MN
55117
Approval for a new manufacturing fixture, and a new in-process destructive test.
P110021/S052
12/7/15
135-Day
SAPIEN Transcatheter Heart Valve Crimper
Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for modifications to the cleaning process for small and large components at the Draper facility.
P120024/S003
12/17/15
180-Day
activL® Artificial Disc
Aesculap Implant Systems, LLC
Center Valley, PA 18034
Approval of the following changes to the post-approval study for the device: changes to the reporting timeline and activL Surgeon Survey.
P130007/S004
12/24/15
Panel-Track
Animas Vibe System
Animas Corp.
West Chester, PA 19380
Approval for the Animas Vibe System. The Animas® Vibe™ System consists of the Animas Vibe Insulin Pump paired with the Dexcom G4 Platinum CGM sensor and transmitter. The Animas Vibe Insulin Pump is intended for the continuous subcutaneous infusion of insulin for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery or as part of the Animas Vibe System to receive and display continuous glucose measurements from the Dexcom G4 PLATINUM Sensor and Transmitter. The Animas Vibe Systems continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (age 2 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM 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 results from the Dexcom G4 PLATINUM Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time. The Animas Vibe System is intended for single patient use in persons age 2 and older and requires a prescription.
P130009/S028
12/7/15
135-Day
Novaflex+ Delivery System, Ascendra+ Delivery System, Edwards Expandable Introducer Sheath Set, and Crimper
Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for modifications to the cleaning process for small and large components at the Draper facility.
P130022/S002
12/2/15
Real-Time
Senza Spinal Cord Stimulation (SCS) System
Nevro Corporation
Menlo Park, CA 94025
Approval for minor changes in the Senza System Implantable Pulse Generator (IPG) and Trial Stimulation (TSM) firmware.
P130026/S005
12/2/15
Real-Time
TactiCath Quartz Set
St. Jude Medical
Plymouth, MN 55442
Approval for a new distal tip adhesive.
P130026/S013
12/22/15
Special
TactiCath Quartz Set
St. Jude Medical
Plymouth, MN 55442
Approval for additional slider race component manufacturing fixtures.
P140004/S002
12/15/15
180-Day
Superion® Interspinous Spacer (ISS)
VertiFlex®, Incorporated
San Clemente, CA 92673
Approval of the post-approval study protocol.
P140004/S003
12/11/15
135-Day
Superion® InterSpinous Spacer
VertiFlex®, Incorporated
San Clemente, CA 92673
Approval for a change in supplier of the following manual instruments: p/n 100-9135, p/n 100-9146, p/n 100-9136, p/n 100-9137, p/n 100-9117, p/n 100-9127, and p/n 100-9139.
P140009/S005
12/18/15
Real-Time
Brio LE Charging System
St. Jude Medical
Plano, Texas
75024
Approval for modifying the internal switch mechanism of the IPG charging device.
P140010/S009
12/4/15
180-Day
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
Medtronic, Inc.
Santa Rosa, CA 95403
Approval for a manufacturing site located at Medtronic Mexico, Tijuana, Baja CA, Mexico.
P140012/S002
12/21/15
180-Day
Reshape Integrated Dual Balloon System
ReShape Medical, Inc.
San Clemente, CA 92672
Approval for 1) a new delivery catheter Gen1; 2) product packaging for the ReShape Integrated Dual Balloon System; 3) extension of the balloon and delivery catheter assembly to 24 months; and 4) a new supplier for the delivery catheter assembly (Medbio, Inc., in Grand Rapids, Michigan).
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
P790005/S053
12/17/15
EBI OsteoGen™ Implantable Bone Growth Stimulators (20μA/M & 20μA/ML, 40μA/M & 40μA/ML)
EBI, LLC, d/b/a Biomet Bone Healing Technologies
Parsippany, NJ 07054
Qualify an alternate supplier for a material used in the device.
P820033/S009
12/3/15
Plasmaflo™ OP-05 W (A) Asahi Plasma Separator
Asahi Kasei Medical Co., Ltd.
Chiyoda-Ku, Japan
101-8101
Add a new vendor for the brominated polycarbonate raw material in the manufacture of the components of the Plasmaflo™ OP-05 W (A) Asahi Plasma Separator.
P830055/S165
12/23/15
LCS Total Knee System
DePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Move from a manual to an automated inspection method and to increase the frequency of this inspection following the machine milling of a slot in the LCS Complete Modular Revision Femoral components manufactured at the DePuy International, Ltd., facility in Leeds, United Kingdom.
P830055/S166
12/15/15
LCS Total Knee System
Depuy Orthopaedics, Incorporated
Warsaw, IN
46580
Change to a new dosimetry system at Steris Isomedix Services (Libertyville, Ohio).
P830061/S123
12/8/15
CapSure Sense Lead and Vitatron Crystalline Lead
Medtronic, Inc.
Mounds View, MN 55112
Supplier change for a coupler component.
P830061/S124
12/16/15
CapSure Sense Lead
Medtronic, Inc.
Mounds View, MN 55112
Change in environmental monitoring from manual readings to an automated software system.
P840001/S317
12/3/15
Restore, Itrel and Synergy Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lead
Medtronic Inc.
Minneapolis, MN 55432
Process changes to the battery burn-in testing for the Restore battery used in the spinal cord stimulation systems.
P840001/S318
12/23/15
Restore, Itrel and Synergy Spinal Cord Stimulator System
Medtronic, Inc.
Minneapolis, MN 55432
Update of the Pull Test Sample Size and Control Limits used for special manufacturing process monitoring in alignment with the Statistical Process Control Program at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
P850035/S040
12/17/15
SpF®-XL IIb 2/DM Implantable Spinal Fusion Stimulators (40 uA) & SpF®-PLUS-Mini (60 uA/M) Spinal Fusion Stimulators
EBI, LLC, d/b/a Biomet Bone Healing Technologies
Parsippany, NJ 07054
Qualify an alternate supplier for a material used in the device.
P880086/S264
12/7/15
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity ADx, and Verity ADx family of pacemaker devices
St. Jude Medical
Sylmar, CA
91342
Use of a mold release agent on header casting assemblies in the above devices.
P880086/S265
12/15/15
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity Adx, Verity Adx family of Pacemaker Devices
St. Jude Medical
Sylmar, CA
91342
Alternate supplier for the B connector (IS-1 connector).
P910001/S081
12/3/15
Excimer Laser Coronary Atherectomy (ELCA) Catheter
Spectranetics Corporation
Colorado Springs, CO
80921
Modification to the Ethylene Oxide (EO) sterilization process.
P910001/S082
12/18/15
Excimer Laser Coronary Atherectomy (ELCA) Catheter
Spectranetics Corporation
Colorado Springs, CO
80921
Change to the proximal marker band fusing process.
P910023/S366
12/15/15
Current, Ellipse, Fortify, and Fortify Assura family of ICD devices
St. Jude Medical
Sylmar, CA
91342
Alternate supplier for the B connector (IS-1 connector).
P910056/S021
12/4/15
EnVista® Hydrophobic Acrylic Intraocular Lens (IOL)
Bausch & Lomb, Inc.
Irvine, CA
92618
Implement a bulk extraction and hydration process for the Model MX60 IOLs.
P920047/S087
12/17/15
Blazer Prime HTD
Boston Scientific Corporation
San Jose, CA
95134
Additional supplier for the steering control wire.
P930014/S087
12/31/15
AcrySof® IQ Toric IOL
Alcon Laboratories, Inc.
Fort Worth, TX 76134
Alcon Laboratories Ireland Ltd., as an alternate Intraocular Lens Manufacturing facility for ACRYSOF® IQ Toric IOL (Models SN6AT6, SN6AT7, SN6AT8, SN6AT9) and the use of the Manual Wet NIMO equipment for the spherical aberration measurement manufacturing process step in place of the current Long Wet Manual Aberrometer system specifically for low diopter (6.0 – 9.5 Diopter) IQ Toric lenses.
P930039/S144
12/16/15
CapSureFix Novus Lead
Medtronic, Inc.
Mounds View, MN 55112
Change in environmental monitoring from manual readings to an automated software system.
P950034/S043
12/3/15
Seprafilm Adhesion Barrier
Genzyme Corporation
Framingham, MA 01701
Change in the software used to manage and print barcodes and labels for the Seprafilm Adhesion Barrier device.
P960009/S242
12/23/15
Activa Deep Brain Stimulation Therapy System
Medtronic, Inc.
Minneapolis, MN 55432
Update of the Pull Test Sample Size and Control Limits used for special manufacturing process monitoring in alignment with the Statistical Process Control Program at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
P960040/S359
12/7/15
DYNAGEN, INOGEN, AND ORIGEN ICDs
Boston Scientific Corporation
St. Paul, MN
55112
Addition of a new manufacturing inspection to verify the polarity of the discrete capacitor array component on the printed circuit board.
P960042/S052
12/3/15
Spectranetics Laser Sheaths (SLS)
Spectranetics Corporation
Colorado Springs, CO
80921
Modification to the Ethylene Oxide (EO) sterilization process.
P970004/S208
12/23/15
InterStim Therapy System for Urinary Control
Medtronic, Inc.
Minneapolis, MN 55432
Update of the Pull Test Sample Size and Control Limits used for special manufacturing process monitoring in alignment with the Statistical Process Control Program at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
P970051/S138
12/30/15
Nucleus 24 Cochlear Implant System
Cochlear Americas
Centennial, CO 80111
Change to the pre-sterilization cleaning process to allow for additional devices to be cleaned prior to the sterilization cycle.
P980006/S025
12/16/15
PureVision® (Single Vision Spherical), PureVision® Toric for Astigmatism, PureVision® Multi-focal for Presbyopia, PureVision2® (Single Vision Spherical), PureVision2® Toric for Astigmatism, and PurVision2® Multi-Focal for Presbyopia
Bausch and Lomb Incorporated
Rochester, NY 14609
Implementation of an alternate raw material supplier.
P980022/S182
12/3/15
Paradigm® REAL-Time System Paradigm® REAL-Time Revel System
Medtronic MiniMed
Northridge, CA 91235
Use harvested motors with separated flex cables in the manufacture of Paradigm Real-Time, Paradigm Real-Time Revel, and MiniMed 530G Insulin Pumps.
P980022/S184
12/4/15
Paradigm REAL-Time Revel System Paradigm REAL-Time System
Medtronic MiniMed
Northridge, CA 91325
Change from a manual to automated process of assembling the motor gearbox of the Paradigm REAL-Time Insulin Pump and Paradigm REAL-Time Revel Insulin Pump. The Paradigm REAL-Time and Paradigm REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time and Paradigm REAL-Time Revel Systems, respectively.
P980022/S186
12/9/15
Paradigm® REAL-Time System, Paradigm® REAL-Time Revel System
Medtronic MiniMed
Northridge, CA 91235
Changes in the incoming inspection criteria for the Blue Test Plug to remove the inspection of 5 non-critical dimensions. The Blue Test Plug is intended for use with the MiniLink Transmitter (MMT-7703) and it is an accessory of Paradigm REAL-Time, Paradigm REAL-Time Revel, and MiniMed 530G Systems.
P980022/S187
12/8/15
Paradigm REAL-Time System and Paradigm REAL-Time Revel System
Medtronic Minimed
Northridge, CA 91325
Manufacturing change regarding the preparation of the Piezo component of the electronic stack assemblies within the Paradigm REAL-Time/REAL-Time REVEL and 530G System pumps; a new preparation fixture is being used to assemble the Piezo component. The affected insulin pumps are components of the Paradigm REAL-Time/REAL-Time REVEL Systems and MiniMed 530G Systems.
P980022/S188
12/9/15
Paradigm Real-Time System, Paradigm Real-Time Revel System
Medtronic MiniMed
Northridge, CA 91325
Updating the inspection specifications of the drive support disk cap of the Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G insulin pumps case surface. The Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G insulin pumps are components of the Paradigm REAL-Time, Paradigm REAL-Time Revel and MiniMed 530G Systems.
P980022/S189
12/23/15
Paradigm Real-Time System, Paradigm Real-Time Revel System
Medtronic MiniMed
Northridge, CA 91325
Transfer of two sub-assembly processes for the Paradigm REAL-Time, Paradigm REAL-Time Revel, and MiniMed 530G insulin pumps from Medtronic MiniMed in Northridge, CA to Medtronic Puerto Rico Operations Company (MPROC). The Paradigm REAL-Time and REAL-Time Revel Insulin Pumps are components of the Paradigm REAL-Time and REAL-Time Revel Systems, respectively. The MiniMed 530G Insulin Pump is a component of the MiniMed 530G System.
P980035/S448
12/16/15
Adapta, Versa, Sensia IPG
Medtronic, Inc.
Mounds View, MN 55112
Change in environmental monitoring from manual readings to an automated software system.
P980037/S051
12/2/15
AngioJet Ultra XMI Thrombectomy Set, Spiroflex, Spiroflex Vg, Distaflex Thromobectomy Set
Boston Scientific Corporation
Minneapolis, MN 55433
Establish an alternate vendor, Boston Scientific Corporation Maple Grove, for the pump sub-assembly component of the AngioJet Ultra Thrombectomy System.
P980037/S052
12/9/15
AngioJet Rheolytic Thrombectomy System
Boston Scientific Corporation
Minneapolis, MN 55433
Change in vendor for the Waste Bag Sub-Assembly and the Bag Spike Sub-Assembly.
P980037/S054
12/18/15
AngioJet Rheolytic Thrombectomy System
Boston Scientific Corporation
Minneapolis, MN 55433
Change to the sub-assembly manufacturing process.
P980040/S063
12/14/15
TECNIS® 1-Piece IOL, TECNIS® OptiBlue 1-Piece IOL, TECNIS® Multifocal 1-Piece IOL
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Permission to automate their manufacturing line.
P980044/S029
12/10/15
SUPARTZ FX
Seikagaku Corporation
Toyko, Japan
100-0005
Sharing the facility and equipment used to manufacture SUPARTZ FX for the purpose of manufacturing of an investigational drug product.
P990046/S043
12/16/15
Open Pivot Heart Valve and Aortic Valved Graft
Medtronic, Inc.
Mounds View, MN 55112
Change to the bioburden monitoring strategy and sterility verification dose monitoring.
P990046/S044
12/16/15
Open Pivot Heart Valve, Open Pivot Aortic Valved Graft
Medtronic, Inc.
Santa Ana, CA 92705
Relocate the fabric vendor’s manufacturing operations to La Coitat, France.
P000025/S083
12/29/15
MED-EL Cochlear Implants: Mi1200 SYNCHRONY, Mi1000 MED-EL CONCERT and SONATA TI100; Insertion Test Device and Insertion Electrode
MED-EL Elektromedizinische Geraete GmbH
Innsbruck, Tirol, Austria
A-6020
Alternatives to batch testing for bacterial endotoxins and establishment of a dynamic sampling plan.
P010001/S014
12/4/15
Transcend® Hip Articulation System
CeramTec GmbH
Plochingen, GERMANY
73207
Addition of one clean room class 7 for the ceramic components of the TRANSCEND Hip Articulation System.
P010012/S404
12/7/15
DYNAGEN, INOGEN, AND ORIGEN CRT-Ds
Boston Scientific Corporation
St. Paul, MN
55112
Addition of a new manufacturing inspection to verify the polarity of the discrete capacitor array component on the printed circuit board.
P010019/S042
12/3/15
Lotraficon B Soft Contact Lenses for Extended Wear O2Optix™, Air Optix® Aqua, Air Optix® for Astigmatism, Air Optix® Aqua Multifocal
Alcon Research LTD.
Fort Worth, TX 76134
To introduce an alternate source/ manufacturer of polypropylene molded blister shells for packaging.
P010030/S069
12/3/15
Lifevest Wearable Defibrillator
Zoll Lifecor Corporation
Pittsburgh, PA 15238
Addition of a new, optional dispensing equipment used in the therapy electrode manufacturing process.
P010030/S071
12/9/15
Lifevest Wearable Defibrillator
Zoll Manufacturing Corporation
Pittsburgh, PA 15238
An additional, pre-approved supplier of a custom component to be used as part of the device in consideration.
P010032/S106
12/4/15
Eon, Eon C, Eon Mini, Protégé, Protégé MRI Systems
St. Jude Medical
Plano, TX
75024
Minor modification on the automated manufacturing test software for both Spinal Cord Stimulation and the Deep Brain Stimulation Implantable Pulse Generators.
P010032/S107
12/9/15
Eon Mini Implantable Pulse Generator (IPG), Protégé IPG, Protégé IPG MRI
St. Jude Medical
Plano, Texas
75024
Removal of a duplicate inspection procedure and changes to minimal tolerances for batteries used in the implantable pulse generators.
P010047/S040
12/11/15
Progel™ Pleural Air Leak Sealant
Neomend, Inc.
Irvine, CA 92618
Phase 1 of the cleanroom expansion plan and allow product to be built and distributed using the expanded cleanroom environment.
P010047/S041
12/17/15
Progel™ Pleural Air Leak Sealant
Neomend, Inc.
Irvine, CA
92618
Alternate supplier of analytical testing services for determination of the total sodium content in bicarbonate buffer solutions.
P020004/S124
12/16/15
GORE EXCLUDER AAA Endoprosthesis
W.L.Gore & Associates, Inc.
Flagstaff, AZ 86005
Implement circumferential tensile testing as a lot acceptance test for the graft component.
P020025/S081
12/17/15
Blazer Prime XP and IntellaTip MiFi XP
Boston Scientific Corporation
San Jose, CA
95134
Additional supplier for the steering control wire.
P030004/S009
12/18/15
Onyx™ Liquid Embolic System and Apollo™ Onyx™ Delivery Micro Catheter
Medtronic Neurovascular
Irvine, CA
92618
Addition of clarification to the Coating Procedure regarding the top coat curing time and the inclusion of an additional weighing balance to the Coating Preparation procedure for the Apollo™ Onyx™ Delivery Micro Catheter.
P030016/S029
12/10/15
Visian Implantable Collamer® Lens for Myopia (MICL)
Staar Surgical Co.
Monrovia, CA 91016
Add the Getinge Autoclave as an alternate sterilizer for the Visian Lens.
P030017/S242
12/4/15
Precision® Spinal Cord Stimulator (SCS) System Precision, Precision Spectra™, and Precision Novi™
Boston Scientific Neuromodulation
Valencia, CA
91355
Updates to the welding schedule for resistance welding of the distal end of splitters, adaptors, and lead extensions.
P030017/S243
12/18/15
Precision Novi Spinal Cord Stimulator (SCS) System
Boston Scientific Corporation Neuromodulation
Valencia, CA
91355
Change in supplier for the 47 μH inductors.
P030022/S034
12/17/15
REFLECTION Ceramic Hip System
Smith & Nephew, Inc.
Cordova, TN
38016
Addition of a new water generator.
P030027/S008
12/30/15
MicroPort Orthopedics, Inc. Ceramic TRANSCEND Articulation
MicroPort Orthopedics, Incorporated
Arlington, TN 38002
Addition of CeramTech’s Marktredwitz facility for the use of the hot isostatic pressure (HIP) process.
P030035/S142
12/7/15
Anthem, Allure RF, Allure Quadra, and Allure Quadra RF family of CRT-P devices
St. Jude Medical
Sylmar, CA
91342
Use of a mold release agent on header casting assemblies in the above devices.
P030035/S143
12/15/15
Anthem, Allure RF, Allure Quadra, Allure Quadra RF family of CRT-P Devices
St. Jude Medical
Sylmar, CA
91342
Alternate supplier for the B connector (IS-1 connector).
P030054/S296
12/15/15
Promote, Quadra Assura, Unify, Unify Assura, Unify Quadra family of CRT-D Devices
St. Jude Medical
Sylmar, CA
91342
Alternate supplier for the B connector (IS-1 connector).
P040002/S057
12/2/15
AFX Endovascular AAA System
Endologix, Inc.
Irvine, CA
92618
Increase in the sterilization load configuration.
P040027/S046
12/15/15
Gore VIATORR TIPS Endoprosthesis
W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
Alternate manufacturing location for the graft component and alternate location for component destructive testing.
P040037/S086
12/2/15
GORE® VIABAHN® Endoprosthesis GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Addition of a next generation machine (Third Generation Automatic, Tape, Align, and Transfer (ATAT)) used in the manufacture of the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface.
P040037/S087
12/2/15
GORE VIABAHN Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ 860005
Implement a process setting change for the Radio Frequency Induction Bonder machine (RF Bonder).
P040045/S053
12/10/15
Vistakon (senofilcon A) Brand Contact Lenses
Johnson & Johnson
Vision Care, Inc.
Jacksonville, FL 32256
Implementation of an alternate raw material process for a senofilcon A monomer components of VISTAKON (senofilcon A) Brand Contact Lenses.
P040043/S078
12/16/15
GORE TAG Thoracic Endoprosthesis
W.L. Gore & Associates, Inc.
Flagstaff, AZ
86005
Implement circumferential tensile testing as a lot acceptance test for the graft component.
P050019/S022
12/17/15
Carotid Wallstent Monorail Endoprosthesis
Boston Scientific Corporation
Maple Grove, MN 55311
Removal of two duplicate inspections during final catheter manufacturing.
P050019/S023
12/16/15
Carotid WALLSTENT Monorail Endoprosthesis
Boston Scientific Corporation
Maple Grove, MN 55311
Modifications to the stent mount process.
P050037/S064
12/29/15
Radiesse, Radiesse (+)
Merz North America, Inc.
Raleigh, NC
27615
Four changes in the manufacturing process of the calcium hydroxylapatite (CaHA) particles in Radiesse.
P050038/S027
12/2/15
Arista AH, Arista AH Flexitip/Fexitip XL/Flexitip XL-R
Davol Incorporated (Subsidiary of C.R. Bard Incorporated)
Woburn, MA
01801
Changes to the Poly/Tyvek pouch packaging used in both Arista FlexiTip XL and FlexiTip XL-R. These changes included 1) Revision to pouch sealing parameters 2) Addition of appearance criteria and revised tolerances to manufactured pouch, and 3) Implementation of a new sealer for the FlexiTip XL pouch.
P050039/S018
12/30/15
Novation Ceramic Articulation Hip System (AHS)
Exactech, Incorporated
Gainesville, FL 32653
Addition of CeramTech’s Marktredwitz facility for the use of the hot isostatic pressure (HIP) process.
P050052/S075
12/29/15
Radiesse, Radiesse (+)
Merz North America, Inc.
Raleigh, NC
27615
Four changes in the manufacturing process of the calcium hydroxylapatite (CaHA) particles in Radiesse.
P060001/S024
12/14/15
Protégé GPS Stent System
ev3 Endovascular, Inc.
Plymouth, MN 55441
Change to the manufacturing equipment for the Protégé GPS Stent System.
P070014/S049
12/9/15
Lifestent Vascular Stent System
Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
New supplier for a component of the delivery system.
P070026/S032
12/10/15
Ceramax Ceramic Hip System
Depuy Orthopaedics, Inc.
Warsaw, IN
46581
Change in inspection method from 100% visual inspection to 100% inspection with a pin gauge at a contract manufacturer.
P070026/S033
12/15/15
CeraMax Ceramic Hip System
Depuy Orthopaedics, Incorporated
Warsaw, IN
46580
Change to a new dosimetry system at Steris Isomedix Services (Libertyville, Ohio).
P080025/S103
12/23/15
Interstim Sacral Nerve Stimulation Therapy System
Medtronic, Inc.
Minneapolis, MN 55432
Update of the Pull Test Sample Size and Control Limits used for special manufacturing process monitoring in alignment with the Statistical Process Control Program at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
P090013/S210
12/16/15
CapSureFix MRI Lead
Medtronic, Inc.
Mounds View, MN 55112
Change in environmental monitoring from manual readings to an automated software system.
P100026/S039
12/9/15
NeuroPace® RNS® System
Neuropace, Inc.
Mountain View, CA 94043
Addition of a cleaning step and cleaning solution to the manufacturing process that produces the Lead Ring Marker.
P100047/S066
12/10/15
HeartWare® Ventricular Assist System
HeartWare, Inc.
Miami Lakes, FL 33014
Implementation of a Connector Assembly Fixture, Connector Gluing Fixture, additional inspections during the manufacturing process and to move the continuity test to further in the manufacturing process.
P100047/S068
12/3/15
HeartWare® Ventricular Assist System
HeartWare, Inc.
Miami Lakes, FL 33014
Implementation of an upgraded computer for the Co-Ordinate Measuring Machine (TS00261-01).
P100047/S069
12/15/15
HeartWare® Ventricular Assist System
HeartWare, Inc.
Framingham, MA 01701
To add a supplier for a critical component, where the specifications are unchanged.
P110010/S117
12/3/15
PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
To automate the ca