Medical Devices

November 2015 PMA Approvals

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P130018
11/24/15
ProACT™ Adjustable Continence Therapy for Men Uromedica, Inc.
Plymouth, MN 55441
Approval for the ProACT Adjustable Continence Therapy for Men. This device is indicated for the treatment of adult men who have stress incontinence arising from intrinsic sphincter deficiency of at least twelve months duration following radical prostatectomy or transurethral resection of the prostate (TURP) and who have failed to respond adequately to conservative therapy.
P130028
11/20/15
Algovita Spinal Cord Stimulation System Algostim, LLC
Blaine, MN
55449
Approval for the Algovita Spinal Cord Stimulation 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 failed back surgery syndrome, intractable low back pain and leg pain.
P140019
11/3/15
i-FACTOR™ Peptide Enhanced Bone Graft Cerapedics, Incorporated
Westminster, CO 80021
Approval for the i-FACTOR Peptide Enhanced Bone Graft. This combination product is indicated for use in skeletally mature patients for reconstruction of a degenerated cervical disc at one level from C3-C4 to C6-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit), with or without neck pain, or myelopathy due to a single-level abnormality localized to the disc space, and corresponding to at least one of the following conditions confirmed by radiographic imaging (CT, MRI, X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels, after failure of at least 6 weeks of conservative treatment. i-FACTOR Peptide Enhanced Bone Graft P-15 Putty must be used inside an allograft bone ring and with supplemental anterior plate fixation.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P830063/S008
11/12/15
Special
Gambro Prismaflex TPE 2000 Set Baxter Healthcare Corporation
Round Lake, IL 60073
Approval for a labeling change to address complaints related to luer connector cracks.
P860003/S081
11/2/15
Real-Time
Therakos® CELLEX® Photopheresis System Therakos, Inc.
West Chester, PA 19380
Approval for the removal of the accelerometer and associated accelerometer alarm from the CELLEX instrument.
P860004/S185
11/9/15
180-Day
SynchroMed Infusion System Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for changes in manufacturing and requirements for select motor assembly components of the SynchroMed II pump.
P860004/S224
11/24/15
180-Day
Synchromed II Programmable Infusion Pump Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for two design changes: 1) Encapsulation of motor feedthroughs with medical adhesive in order to reduce system failures from feedthrough shorting; and 2) The addition of an impedance requirement to ensure electrical isolation of the motor circuit.
P910056/S019
11/19/15
135-Day
Envista® Hydrophobic Intraocular Lens Bausch & Lomb
Irvine, CA
92618
Approval for an alternate component supplier for the acrylic sheet used to mill enVista hydrophobic intraocular lens buttons (Model MX60). Specifically, the sheet manufacturing process is to alternatively transfer to the Bausch and Lomb facility in Wilmington, Massachusetts (WIL).
P910073/S122
11/6/15
180-Day
ENDOTAK RELIANCE S, ENDOTAK RELIANCE G/SG, and ENDOTAK RELIANCE DF4 Defibrillation leads Boston Scientific Corporation
St Paul, MN
55112
Approval for the following: 1) A sterilization process change from Oxyfume to 100% Ethylene Oxide; 2) Drug specification changes; and 3) Corresponding labeling changes.
P960009/S211
11/4/15
180-Day
Activa Deep Brain Stimulation Therapy System Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for 1) expanded MRI conditions for Medtronic DBS systems; 2) updates to the Model 37651 Patient Recharger System; 3) clarifications to the guidelines for conducting CT scans on DBS patients; 4) addition of symbols to sterile and shelf-box package labels for specified models; and (5) updates to package configurations for specified models.
P960009/S229
11/17/15
180-Day
Medtronic DBS Therapy for Parkinson's Disease Medtronic, Inc.
Minneapolis, MN 55432
Approval for a modification to the indication for use (IFU) for the Medtronic Deep Brain Stimulation (BDS) therapy for Parkinson's disease and corresponding labeling changes associated with the IFU modification. Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS Therapy for Parkinson's Disease is indicated for adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson's disease of at least 4 years' duration that are not adequately controlled with medication.
P960058/S116
11/24/15
180-Day
HiResolution Bionic Ear System Advanced Bionics, LLC
Valencia, CA
91355
Approval for a manufacturing site located in Valencia, California
N970003/S182
11/3/15
Real-Time
Altrua 2, Essentio, Proponent, and Accolade Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Approval for design changes to the accelerometer component and associated changes.
P970051/S131
11/19/15
135-Day
Cochlear CI500 Series Implants Cochlear Americas
Peakview Avenue
Centennial, CO 80111
Approval for the manufacturing specification tolerances for three areas of the Top Shell (depth, doming in center, and flatness of chassis mating edge), a component of the implant casing.
P980016/S559
11/25/15
180-Day
Maximo II ICD, Protecta ICD , Protecta XT ICD, Virtuoso II
DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Approval for the L409 IC design and associated manufacturing changes, which is used in the devices.
P980022/S146
11/23/15
135-Day
Paradigm® REAL-Time System and Paradigm® REAL-Time Revel System Medtronic MiniMed
Northridge, CA 91325
Approval for changes in the welding process of the clear plastic window to the pump case of the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K), the Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K) and the MiniMed 530G Insulin Pump (Model: MMT-551). The Paradigm REAL-Time Insulin Pump is a part of the Paradigm REAL-Time System; the Paradigm REAL-Time Revel Insulin Pump is a part of the Paradigm REAL-Time Revel system; and the MiniMed 530G Insulin Pump is a part of the MiniMed 530G System.
P980022/S159
11/12/15
180-Day
Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REALTime, CGM System, MiniLink REAL-Time System, iPro Recorder CGM System, iPro2 Professional CGM System Medtronic Minimed Inc.
Northridge, CA 91325
Approval for an incoming receiving material specification change of a critical device component (GOx) used in the sensor fabrication process for the Enlite Sensor (MMT-7008) and Sof-Sensor (MMT-7002, MMT-7003). These sensors are components of the MiniMed 530G System and Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, iPro Recorder CGM System, and iPro2 Professional CGM System, respectively.
P980035/S445
11/25/15
180-Day
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Approval for the L409 IC design and associated manufacturing changes, which is used in the devices.
P980037/S050
11/2/15
180-Day
AngioJet Rheolytic Thrombectomy System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located in Fremont, California for finished device release test, packaging and labeling.
P000006/S045
11/23/15
Real-Time
Titan Inflatable Penile Prosthesis Coloplast Corp.
Minneapolis, MN 55411
Approval for changes to the hydrophilic coating specifications and manufacturing process.
P010015/S286
11/25/15
180-Day
Consulta CRT-P, Syncra CRT-P,
Viva CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Approval for the L409 IC design and associated manufacturing changes, which is used in the devices.
P010030/S053
11/6/15
Real-Time
Lifevest Wearable Defibrillator Zoll Manufacturing Corporation
Pittsburgh, PA 15238
Approval for the LifeVest Wearable Defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.  The device as modified is approved for 1) Change to the length of the therapy electrode channel foam; 2) Change to the dimensional tolerances of the hole locations on the therapy electrode lidding layer; 3) Change from adhesive to crimping of the battery connector and reinforcement of the battery cells within the WCD 4000 pack; and 4) Change of material of the hex nut used in the WCD 4000 monitor electrode belt receptacle from brass to stainless steel.
P010030/S054
11/6/15
Real-Time
LifeVest® Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA 15238
Approval for an alternate supplier of an off-the-shelf SDRAM integrated circuit (IC) used on the LifeVest® Wearable Defibrillator Model WCD 4000 Computer Printed Circuit Board Assemblies (PCA). The alternate supplier is Integrated Silicon Solutions Inc. (ISSI). The device, as modified, will be marketed under the trade name LifeVest Wearable Defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
P010030/S059
11/6/15
180-Day
LifeVest® Wearable Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA 15238
Approval for: 1) Redesigned ECG and Belt Node PCAs; 2) Addition of a ferrite bead to the trunk cable assembly and modification to the belt node plastic enclosure; 3) Connectorized Therapy Electrode (TE); 4) Therapy Electrode gas generator plastic enclosure inspection window; 5) Addition of an accelerometer to the front TE and additional conductors to the cable assemblies; and 6) Addition of the PTE advisory labels to the electrode belt.
P010030/S063
11/6/15
Real-Time
LifeVest Wearable Defibrillator 4000 Zoll Manufacturing Corporation
Pittsburgh, PA 15238
Approval for V07.5 monitor Software which includes nine software changes to the LifeVest Wearable Defibrillator 4000 Monitor, The device, as modified, will be marketed under the trade name LifeVest Wearable Defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
P010030/S064
11/6/15
Real-Time
LifeVest Wearable Defibrillator 4000 Zoll Manufacturing Corporation
Pittsburgh, PA 15238
Approval for two electrical design changes for the LifeVest Wearable Defibrillator 4000 monitor pulse delivery circuitry. These changes include and increase the values of four DC blocking capacitors on the defibrillator PCA and two bulk capacitors on the monitor Computer/Analog (C/A) board, as well as change the DC blocking capacitor dielectric from Y5V to X7R and the addition of ferrite bead to the battery power wire on the C/A board. The device, as modified, will be marketed under the trade name LifeVest Wearable Defibrillator 4000 and is indicated for adult patients who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
P010031/S519
11/25/15
Real-Time
Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D,
Protecta CRT- D,
Protecta XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Approval for the L409 IC design and associated manufacturing changes, which is used in the devices.
P010032/S096
11/2/15
180-Day
Proclaim Neurostimulation System St. Jude Medical
Plano, TX,
75024
Approval for Proclaim Neurostimulation System.
P010032/S098
11/2/15
Real-Time
Genesis Programmer, Eon Patient Programmer, Protégé Programmer, Patient Programmer – MRI St. Jude Medical
Plano, TX
75024
Approval for an alternative resin material (C1200HF) to be used in the manufacture of the outer casing of the Genesis Programmer, Eon Patient Programmer, Protégé Programmer, Patient Programmer -MRI, and Brio Patient Programmer.
P0200036/S033
11/25/15
135-Day
S.M.A.R.T.® CONTROL® Nitinol Stent System Cordis Corp.
Fremont, CA
94555
Approval for removal of perfluoro-octanoic acid (PFOA) from the Polytetrafluoro-ethylene (PTFE) tubing.
P030005/S129
11/3/15
Real-Time
Valitude and Valitude X4 CRT-Ps Boston Scientific Corporation
St. Paul, MN
55112
Approval for design changes to the accelerometer component and associated changes.
P030011/S032
11/27/15
180-Day
SynCardia temporary Total Artificial Heart (TAH-t) System SynCardia Systems, Inc.
Tucson, AZ
85713
Approval of the following changes to the post-approval study for the device:  modification to the approved Post Approval Study for the Companion 2 Driver System, which uses the INTERMACS Registry as the data collection mechanism (INTERMACS Companion).
P030011/S034
11/2/15
Real-Time
SynCardia temporary Total Artificial Heart (TAH-t) SynCardia Systems, Inc.
Tucson, AZ
85713
Approval for a firmware upgrade to the single board computer of the Companion 2 Driver System.
P030017/S234
11/12/15
Real-Time
Precision™, Precision Spectra™, Precision Novi™ Spinal Cord Stimulator (SCS) Systems Boston Scientific Corp.
Valencia, CA
91355
Approval for a minor design change to the plug used in the distal tip of the 1x16 Infinion Leads to make the tip plug of the 1x16 Infinion lead similar to the tip plug of the Infinion CX lead.
P030023/S004
11/13/15
180-Day
OPHTEC Capsular Tension Ring, RingJect, Preloaded Single-Use Capsular Tension Ring (CTR) Injector System Ophtec USA, Inc.
Boca Raton, FL 33487
Approval to include the RingJect, a disposable injector/ delivery system designed for use with Capsular Tension Rings (CTRs), addition of the injector into the same sterile packaging process as the CTR and modification of the packaging configuration to accommodate the combined injector and the preloaded CTR. The device, as modified, will be marketed under the trade name RingJect, Model 375 and Model 376. CTRs are indicated for the stabilization of weakened, broken, or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curbilinear capsulorhexis techniques in adults.
P030047/S029
11/25/15
135-Day
Synchromed II Programmable Infusion Pump Cordis Corp.
Fremont, CA
94555
Approval for removal of perfluoro-octanoic acid (PFOA) from the Polytetrafluoro-ethylene (PTFE) tubing.
P040024/S088
11/23/15
Special
Restylane-L Galderma Laboratories L.P.
Forth Worth, TX 76177
Approval for additional language in patient and provider labeling regarding the risk of intravascular injection of soft tissue fillers.
P040024/S089
11/23/15
Special
Restylane-L Galderma Laboratories L.P.
Forth Worth, TX 76177
Approval for additional language in patient and provider labeling regarding the risk of intravascular injection of soft tissue fillers.
P040047/S040
11/12/15
135-Day
Coaptite Injectable Implant Merz North America, Inc.
Franksville, WI 53126
Approval for adjustments of the standard curve range for endotoxin testing of the Coaptite and Radiesse products.
P050033/S018
11/3/15
135-Day
Hydrelle Dermal Filler Anika Therapeutics, Incorporated
Bedford, MA
01730
Approval of an alternate supplier of a material used in the manufacture Hydrelle.
P050037/S059
11/12/15
135-Day
Radiesse Injectable Implant Merz North America, Inc.
Franksville, WI 53126
Approval for adjustments of the standard curve range for endotoxin testing of the Coaptite and Radiesse products.
P050052/S065
11/12/15
135-Day
Radiesse Injectable Implant Merz North America, Inc.
Franksville, WI 53126
Approval for adjustments of the standard curve range for endotoxin testing of the Coaptite and Radiesse products.
P050052/S069
11/23/15
180-Day
Radiesse® Dermal Filler Merz North America, Inc.
Franksville, WI 53126
Approval of the post-approval study protocol.
P060038/S024
11/24/15
Real-Time
Mitroflow Aortic Pericardial Heart Valve Sorin Group Canada, Inc.
Burnaby, Canada
V5J 5M1
Approval for revisions to the MRI safety labeling.
P080020/S018
11/25/15
180-Day
Gel-One® Seikagaku Corporation
Tokyo, Japan
100-0005
Approval for a change to the manufacturing and storing of Gel-One® to allow for the refrigeration (5°C ± 3°C) of in-process product (i.e. product that has not yet been packaged and labeled) for a maximum of 6 months following the date of terminal steam sterilization and prior to initiation of the product's previously established 12 month shelf life when stored below 25°C (without freezing).
P100009/S010
11/18/15
180-Day
MitraClip Delivery System Abbott Vascular
Santa Clara, CA 95054
Approval for a manufacturing site located at Sterigenics US, LLC, in Los Angeles, California.
P100025/S009
11/23/15
180-Day
BreathTek® UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) Otsuka America Pharmaceutical, Inc.
Rockville, MD 20850
Approval for (1) a new regulatory analytical reference method for analysis of the final drug product, Pranactin-Citric, the drug component of the BreathTek UBT for H. pylori Kit (BreathTek UBT Kit); and (2) the addition of AAIPharma Services Corporation (AAIPharma) in  Wilmington, North Carolina (FEI Number 1049418) as a second analytical testing facility for Pranactin-Citric.
P100033/S004
11/12/15
135-Day
Progensa PCA3 Assay Hologic, Inc.
San Diego, CA 92121
Approval for the introduction of a new vial filler (the Capmatic Linear Bambino Filling System) at the GCD1 manufacturing facility.
P100042/S007
11/24/15
180-Day
APTIMA® HPV Assay Hologic, Incorporated
San Diego, CA 92121
Approval for a change to the Aptima HPV Assay Software from version 4.2.0 to version 4.2.1. This change is being implemented to reduce the probe reagent mixing speed in the hybridization protection assay (HPA) incubator from 14 Hz to 5 Hz on the Tigris System. The device, as modified, will be marketed under the trade name APTIMA® HPV Assay. The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens collected in ThinPrep Pap Test vials containing PresesrvCyt Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the APTIMA HPV Assay. The assay is used with the TIGRIS DTS System or the PANTHER System.
P110027/S009
11/9/15
180-Day
therascreen KRAS RGQ PCR Kit QIAGEN Manchester Ltd.
Manchester, UK M15 6SH
Approval for a manufacturing site located at QIAGEN GmbH in Hilden, Germany.
P110035/S032
11/30/15
180-Day
Epic Vascular Nitinol Self-Expanding Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Boston Scientific Ireland Ltd., in Galway, Ireland.
P110038/S010
11/18/15
Special
Relay Thoracic Stent-Graft With Plus Delivery System Bolton Medical, Inc.
Sunrise, FL
33325
Approval for an additional inspection step of the release grip.
P120002/S009
11/25/15
135-Day
S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent System Cordis Corp.
Fremont, CA
94555
Approval for removal of perfluoro-octanoic acid (PFOA) from the Polytetrafluoro-ethylene (PTFE) tubing.
P120005/S038
11/6/15
Real-Time
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Approval for a change in the packaging design for the sensor/ applicator for the G4 Platinum CGM System and the manufacturing line for this new packaging.
P120005/S040
11/25/15
135-Day
Dexcom G5 Mobile Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Approval for adding a second manufacturer for printed circuit board assemblies to be used in the Dexcom G5 transmitter and receiver.
P120010/S004
11/23/15
135-Day
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
Approval for changes in the welding process of the clear plastic window to the pump case of the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K), the Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K) and the MiniMed 530G Insulin Pump (Model: MMT-551). The Paradigm REAL-Time Insulin Pump is a part of the Paradigm REAL-Time System; the Paradigm REAL-Time Revel Insulin Pump is a part of the Paradigm REAL-Time Revel system; and the MiniMed 530G Insulin Pump is a part of the MiniMed 530G System.
P120010/S029
11/12/15
180-Day
MiniMed 530G System Medtronic Minimed Inc.
Northridge, CA 91325
Approval for an incoming receiving material specification change of a critical device component (GOx) used in the sensor fabrication process for the Enlite Sensor (MMT-7008) and Sof-Sensor (MMT-7002, MMT-7003). These sensors are components of the MiniMed 530G System and Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, iPro Recorder CGM System, and iPro2 Professional CGM System, respectively.
P120019/S007
11/13/15
Panel-Track
cobas® EGFR Mutation Test v2 Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for the cobas EGFR Mutation Test v2. This device is indicated for: The cobas EGFR Mutation Test v2 is a real-time PCR test for the qualitative detection of defined mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded tumor tissue (FFPET) from non-small cell lung cancer (NSCLC) patients. The test is intended to aid in identifying patients with NSCLC whose tumors have defined EGFR mutations and for whom safety and efficacy of a drug have been established as follows: Tarceva (erlotinib)/Exon 19 deletions and L858R and Tagrisso (osimertinib) T790M.  Drug safety and efficacy have not been established for the following EGFR mutations also detected by the cobas EGFR Mutation Test v2: Tarceva (erlotinib)/G719X, exon 20 insertions, T790M, S768I and L861Q/Tagrisso (osimertinib)/ G719X, exon 19 deletions, L858R, exon 20 insertions, S768I, and L861Q.  For manual sample preparation, FFPET specimens are processed using the cobas DNA Sample Preparation Kit and the cobas z 480 analyzer is used for automated amplification and detection.
P120022/S012
11/9/15
180-Day
therascreen EGFR RGQ PCR Kit QIAGEN Manchester Ltd.
Manchester, UK M15 6SH
Approval for a manufacturing site located at QIAGEN GmbH in Hilden, Germany.
P120024/S002
11/4/15
Real-Time
activL® Artificial Disc Aesculap Implant Systems, LLC
Center Valley, PA 18034
Approval for changes to the activL Artificial Disc labeling that proposed changes to the Instructions for Use, Surgical Technique, Patient Brochure, and package label to reflect the MR testing that was conducted.
P130005/S007
11/30/15
180-Day
Diamondback Orbital Atherectomy System (OAS) Cardiovascular Systems Inc.
St. Paul, MN
55112
Approval for a manufacturing site located at Cardiovascular Systems Inc., in St. Paul, Minnesota.
P130007/S008
11/3/15
Real-time
Animas® Vibe™ System Animas Corporation
West Chester, PA 19380
Approval for replacing the flash memory of the Printed Circuit Board Assembly (PCBA) used in the Animas Vibe Insulin Pump, a component of the Animas Vibe System, as well as subsequent software changes.
P130021/S016
11/10/15
180-Day
Medtronic CoreValve™ System and Medtronic CoreValve™ Evolut™ R System Medtronic CoreValve LLC
Santa Rosa, CA 95403
Approval for modifying the labeling to remove the precautions regarding patients with low flow/low gradient and end-stage renal disease.
P130024/S003
11/23/15
135-Day
Lutonix Drug Coated Balloon Lutonix, Inc.
New Hope, MN
55428
Approval to change the particulate specification for the  device at lot release and stability testing.
P130024/S005
11/20/15
180-Day
Lutonix 035 Drug Coated Balloon PTA Catheter Lutonix, Inc.
New Hope, MN 55428
Approval for the addition of the 7 x 40 mm and 7 x 60 mm device sizes. The device, as modified, will be marketed under the trade name Lutonix 035 Drug Coated Balloon PTA Catheter and is indicated for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
P130024/S008
11/24/15
Special
Lutonix Drug Coated Balloon PTA Catheter Lutonix, Inc.
New Hope, MN
55428
Approval for changes to the Instructions for Use to provide details regarding the use of bare metal stents with the device for bailout stenting.
P130026/S009
11/17/15
Real-Time
TactiCath Quartz Set St. Jude Medical
Plymouth, MN 55442
Approval for changes to the optical sensor analyzers in the TactiCath Quartz Equipment.
P140003/S001
11/13/15
180-Day
Impella 2.5 System Abiomed, Inc.
Danvers, MA
01923
Approval of the post-approval study protocol.
P140003/S006
11/3/15
Real-Time
Impella 2.5 System Abiomed, Inc.
Danvers, MA
01923
Approval for an upgrade of the Automated Impella Controller (AIC) software to version 5.0.
P140004/S001
11/18/15
180-Day
Superion® InterSpinous Spacer (ISS) VertiFlex®, Incorporated
San Clemente, CA 92673
Approval of Post-Approval Study 1 for the device.
P140009/S002
11/2/15
Real-Time
Brio Neurostimulation System St. Jude Medical
Plano, Texas
75024
Approval for an alternative resin material (C1200HF) to be used in the manufacture of the outer casing of the Genesis Programmer, Eon Patient Programmer, Protégé Programmer, Patient Programmer -MRI, and Brio Patient Programmer.
P140020/S003
11/18/15
Real-Time
BRACAnalysis CDx™ Myriad Genetic Laboratories, Inc.
Salt Lake City, UT 84108
Approval for clarifications to the intended use statement, as follows: BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants, who are or may become eligible for treatment with Lynparza (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located in Salt Lake City, Utah.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N12159/S035
11/27/15
SURGICEL Fibrillar Absorbable Hemostats Ethicon Inc.
Somerville, NJ 08876
Implement a new custom designed piece of automated cutting equipment to cut the product to its final form.
N970003/S183
11/19/15
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE Boston Scientific Corporation
St. Paul, MN
55112
Automation of the sterile packaging process.
P790002/S033
11/6/15
Biomet EBI Bone Healing System Zimmer Biomet
Parsippany, NJ 07054
Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.
P790005/S052
11/6/15
EBI OsteoGen Implantable Bone Growth Stimulators Zimmer Biomet
Parsippany, NJ 07054
Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.
P790007/S046
11/4/15
Hancock Modified Orifice Valved Conduit Model Medtronic, Inc.
Santa Ana, CA 92705
The addition of three new porcine tissue suppliers.
P830055/S164
11/12/15
LCS Total Knee System Depuy Orthopaedics, Inc.
Warsaw, IN 
46581
Addition of a two dimensional (2D) barcode to the distal post of the LCS Complete RP tibial knee inserts and changes to the inspection process.
P840001/S315
11/10/15
External Neurostimulator; Itrel 4 Programmable Neuro-stimulator for Spinal Cord Stimulation; RestorePrime Neurostimulator; PrimeAdvanced Neurostimulator; RestoreUltra Neurostimulator; RestoreAdvanced Neurostimulator; RestorSensor Neurostimulator; PrimeAdvanced SureScan MRI Neurostimulator; RestoreUltra SureScan MRI Rechargeable Neurostimulator; RestoreAdvanced SureScan MRI Rechargeable Neurostimulator; RestoreSensor SureScan MRI Rechargeable Neurostimulator Medtronic Inc.
Minneapolis, MN 55432
The update of manufacturing process changes in the surface treatment of metal piece part for the impacted implatable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P840001/S316
11/20/15
Itrel and Restore SCS Systems Medtronic, Inc.
Minneapolis, MN 55432
Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component Center (Brooklyn Center, MN).
P850022/S026
11/6/15
Biomet OrthoPak Non-Invasive Bone Growth Stimulators & Biomet SpinalPak Non-Invasive Spine Fusion Stimulators Zimmer Biomet
Parsippany, NJ 07054
Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.
P850035/S039
11/6/15
SpF XL IIb Implantable Spinal Fusion Stimulators & SpF-PLUS-Mini Spinal Fusion Stimulators Zimmer Biomet
Parsippany, NJ 07054
Implementation of a new solder reflow oven in the production of the printed circuit boards for the devices above.
P850079/S069
11/12/15
Frequency Xcel toric XR (methafilcon A) Soft (Hydrophilic) Extended Wear Contact Lens CooperVision, Inc.
Pleasanton, CA 94588
The transfer of Frequency Xcel toric XR (methafilcon A) Soft (Hydrophilic) Extended Wear Contact lenses manufacturing process from Dry Line S to Dry Line 1.
P860004/S239
11/4/15
Medtronic SynchroMed II Infusion System Medtronic Neuromodulation
Minneapolis, MN 55432
Relocate the supplier manufacturing facility for the rotor assembly and the finished motor component of the SynchroMed II motor, as well as replace existing equipment (laser marking equipment and tool maker’s microscope) in the motor manufacturing process.
P860004/S240
11/10/15
SynchroMed II Infusion System Medtronic Inc.
Minneapolis, MN 55432
Update of manufacturing process changes in the surface treatment of metal piece part for the impacted implantable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P860004/S241
11/19/15
 
Medtronic SynchroMed II Infusion System Medtronic Neuromodulation
Minneapolis, MN 55432
Move the gear cutting process for the SynchroMed II motor gears and pumphead gear (gears 1, 2, and 3 and pump head gear used in the motor design from Hajime to Seiko where the motor gears are currently manufactured.
P860004/S242
11/20/15
SynchroMed II Infusion System Medtronic, Inc.
Minneapolis, MN 55432
Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component (Brooklyn Center, MN).
P870078/S030
11/4/15
Hancock Low Porosity Valved Conduit Model Medtronic, Inc.
Santa Ana, CA 92705
The addition of three new porcine tissue suppliers.
P890003/S340
11/4/15
MyCareLink Smart Monitor Patient Reader Medtronic, Inc.
Mounds View, MN 55112
The addition of a secondary system level test after final assembly at the supplier.
P910061/S022
11/5/15
Silicone Softport/Soflex Intraocular Lenses (IOLs) Bausch & Lomb, Inc.
Irvine, CA
92618
Changing the tensile force to break specification, adding an elongation to break specification, and adjusting the sampling plan for your haptic material.
P920015/S167
11/18/15
Sprint Quattro Lead Medtronic, Inc.
Mounds View, MN 55112
Changes to passivation process parameter settings and updates to sample sizes used for in process/final inspection at a supplier for several components of the subject lead.
P930014/S086
11/19/15
AcrySof® Single-Piece Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX 76134
Change to a new measurement for quality control inspection of optical performance of your AcrySof® monofocal and toric IOLs at the Ireland facility (Models SA/N60WF, SA/N60AT, SN6AT3-T5).
P930039/S143
11/18/15
CapSureFix, CapSureFix Novus, and Vitatron Crystalline Active Fixation Leads Medtronic, Inc.
Mounds View, MN 55112
Changes to passivation process parameter settings and updates to sample sizes used for in process/final inspection at a supplier for several components of the subject leads.
P950005/S059
11/5/15
Celsius DS Ablation Catheter Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P960009/S240
11/10/15
External Neurostimulator; Activa PC Neurostimulator; Activa SC Neurostimulator; Activa RC Neurostimulator Medtronic Inc.
Minneapolis, MN 55432
Update of manufacturing process changes in the surface treatment of metal piece part for the impacted implantable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P960009/S241
11/20/15
Activa DBS System Medtronic, Inc.
Minneapolis, MN 55432
Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component Center (Brooklyn Center, MN).
P960016/S058
11/17/15
Livewire TC Cardiac Ablation System St. Jude Medical
St. Paul, MN
55117
Replacement of a manual measuring process with an automated measuring system.
P960040/S358
11/19/15
ORIGEN EL ICD, INOGEN EL ICD, DYNAGEN EL ICD, ORIGEN MINI ICD, INOGEN MINI ICD, DYNAGEN MINI ICD Boston Scientific Corporation
St. Paul, MN
55112
Automation of the sterile packaging process.
P970003/S186
11/20/15
Cyberonics VNS Therapy System Cyberonics, Inc.
Houston, TX
77058
Use of a new helium leak tester in the manufacturing process of pulse generators.
P970003/S187
11/25/15
VNS Therapy® System Cyberonics, Inc.
Houston, TX
77058
Addition of alternate weld parameters for the Model 303 implantable lead for the VNS Therapy® System.
P970004/S206
11/10/15
InterStim II Neurostimulator Medtronic Inc.
Minneapolis, MN 55432
Update of manufacturing process changes in the surface treatment of metal piece part for the impacted implatable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P970004/S207
11/20/15
InterStim Therapy System Medtronic, Inc.
Minneapolis, MN 55432
Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component Center (Brooklyn Center, MN).
P970031/S051
11/4/15
Freestyle Aortic Root Bioprosthesis Medtronic Inc.
Santa Ana, CA 92705
Addition of three new porcine tissue suppliers.
P970051/S135
11/12/15
CI500 Series Cochlear Implants Cochlear Americas
Centennial, CO 80111
New supplier and a change in the upper tolerance specification of the 25 micron platinum iridium wire.
P970051/S136
11/20/15
Nucleus CI 512 and 522 Cochlear Implants Cochlear Americas
Centennial, CO 80111
Introduction of an additional cleaning step to remove primer residue prior to curing from the weld surface of the Nucleus CI 500 series implants (Nucleus CI512 and 522).
P980016/S557
11/12/15
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuose II DR/VR ICD Medtronic, Inc.
Mounds View, MN 55112
Update to the manufacturing test software for an integrated circuit used in the devices.
P980035/S444
11/12/15
Advisa DR IPG, Advisa SR MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Update to the manufacturing test software for an integrated circuit used in the devices.
P980043/S052
11/4/15
Hancock II Porcine Bioprosthesis Models Medtronic Inc.
Santa Ana, CA 92705
Addition of three new porcine tissue suppliers.
P990012/S023
11/24/15
Elecsys HBsAG Immunoassay, Elecsys HBsAG Confirmatory, and Elecsys PreciControl HBsAg Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P990025/S047
11/5/15
Navistar Ablation Catheter Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P990027/S020
11/5/15
Technolas 217A Excimer Laser and Technolas 217z Zyoptix Systems Technolas Perfect Vision GmbH
San Francisco, CA 94117
Replacement of the supplier of one component of your treatment card by two other suppliers.
P990056/S022
11/24/15
Elecsys Total PSA Roche Diagnostics
Indianapolis, IN 46250
Change in the testing procedure for the streptavidin-coated microparticles component used as the solid phase in Elecsys immunoassays.
P990064/S061
11/4/15
Mosaic Porcine Bioprosthesis Models Medtronic Inc.
Santa Ana, CA 92705
Addition of three new porcine tissue suppliers.
P990075/S034
11/20/15
Spectrum and Saline Breast Implants Mentor Worldwide LLC.
Somerville, NJ 08876
Changes in the manufacturing process of the primary packaging equipment, and defect classification of the primary packaging visual inspection procedure.
P000013/S012
11/5/15
Trident Ceramic-on-Ceramic Acetabular System Howmedica Osteonics Corp.
Mahwah, NJ
07430
Addition of a Co-ordinate Measuring Machine (CMM).
P000027/S021
11/24/15
Elecsys Freee PSA Roche Diagnostics
Indianapolis, IN 46250
Change in the testing procedure for the streptavidin-coated microparticles component used as the solid phase in Elecsys immunoassays.
P000044/S033
11/20/15
VITROS® Immunodiagnostic Products HBsAg Reagent Pack, VITROS® Immunodiagnostic Products HBsAg Confirmatory Kit, and VITROS® Immunodiagnostic Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Replacement of a raw material with an equivalent material and to add suppliers for the new material.
P010012/S403
11/19/15
DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN  CRT-D, ORIGEN X4 CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Automation of the sterile packaging process.
P010014/S053
11/20/15
Oxford Partial Knee System Biomet, Incorporated
Warsaw, IN
46581
Addition of approved manufacturing coolants during production of components.
P010015/S284
11/12/15
Consulta CRT-P, Syncra CRT-P, Viva CRT-P Medtronic, Inc.
Mounds View, MN 55112
Update to the manufacturing test software for an integrated circuit used in the devices.
P010031/S518
11/12/15
Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D,Protecta XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
Update to the manufacturing test software for an integrated circuit used in the devices.
P010032/S103
11/5/15
Genesis and Eon family Spinal Cord Stimulation (SCS) Systems-External Pulse Generator, 2 Port Header used with EPG St. Jude Medical
Plano, TX
75024
Implementation of updates to the test equipment and measurement techniques used during the manufacturing process of the micro HDMI connector of the SJM EPG Header Model 3032.
P010032/S104
11/6/15
Eon, EonC, Eon Mini, Protégé, Protégé MRI Systems St. Jude Medical
Plano, TX
75024
Use an alternative batch test method for endotoxin monitoring for the Genesis/Eon/EonC/Eon Mini/Protégé/Brio families of devices.
P010032/S105
11/6/15
Eon, EonC, Eon Mini, Protégé, Protégé MRI Implantable Pulse Generators (IPGs) St. Jude Medical
Plano, TX
75024
Acceptance of the addition of an alternate supplier for the Implantable Pulse Generator (IPG) Weld Level sub-assemblies.
P010054/S025
11/24/15
Elecsys Anti-HBs Immunoassay, Elecsys PreciControl Anti-HBs, and Elecsys Anti-HBS CalCheck Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P010068/S049
11/5/15
Navistar, Celsius, Celsius FLTR, and Navistar DS Ablation Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P020036/S035
11/5/15
Cordis S.M.A.R.T. Control Nitinol Stent System Cordis Corporation
Fremont, CA
94555
Change to the manufacturing location of your supplier for the internal packaging pouches.
P020045/S068
11/12/15
 
Freezor Cardiac CryoAblation Catheter, Freezor Xtra Surgical Cardiac CryoAblation Device, Freezor Max Surgical Cardiac CryoAblation Device Medtronic Cryocath Lp
Quebec, Canada
H9R 5Z8
Changes to Smart Chip programming equipment and verification.
P030005/S130
11/19/15
VALITUDE, VALITUDE X4 Boston Scientific Corporation
St. Paul, MN
55112
Automation of the sterile packaging process.
P030016/S028
11/17/15
Visian Implantable Collamer Lens for Myopia (micl) Staar Surgical Co.
Monrovia, CA 91016
Replacement of an instrument to measure dioptric power and image quality (MTF) at final product inspection.
P030017/S238
11/18/15
PrecisionTM, Precision SpectraTM, and Precision NoviTM Spinal Cord Stimulator (SCS) Systems Boston Scientific Neuromodulation
Valencia, CA
91355
Use of an alternate degreasing chemical during the vapor degreasing process of the set screws, end stops, and feed through blanks used in IPG headers and lead extensions.
P030017/S239
11/18/15
Precision Spinal Cord Stimulator (SCS) System Boston Scientific
Valencia, CA
91355
Use of an alternate welder used in the connector stack assembly process of your Implantable Pulse Generator.
P030017/S240
11/24/15
Precision Spectra and Precision Novi IPGs Boston Scientific Corp.
Valencia, CA
91355
Use of an updated test equipment system used for testing the Precision Spectra Remote Control used to support the Precision Spectra IPG and the FreeLink Remote Control used to support both Precision Spectra and Precision Novi IPGs.
P030026/S031
11/3/15
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc IgM Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY 14626
Change for the introduction of a new piece of manufacturing equipment to pack coated wells into reagent packs.
P030031/S071
11/5/15
Celsius ThermoCool, ThermoCool SF, Navistar ThermoCool, ThermoCool SF NAV, and ThermoCool SmartTouch Ablation Catheters Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P030036/S080
11/18/15
SelectSecure Lead Medtronic, Inc.
Mounds View, MN 55112
Changes to passivation process parameter settings and updates to sample sizes used for in process/final inspection at a supplier for several components of the subject lead.
P030039/S019
11/24/15
Coseal Surgical Sealant Baxter Healthcare Corp.
Round Lake, IL 60073
Change in resin used in the molding of several delivery system components.
P030053/S052
11/20/15
MemoryGel Breast Implants Mentor Worldwide LLC.
Somerville, NJ 08876
Changes in the manufacturing process of the primary packaging equipment, and defect classification of the primary packaging visual inspection procedure.
P040002/S056
11/18/15
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Alternate supplier to perform microbiological testing.
P040024/S087
11/6/15
Restylane, Restylane-L, Restylane Lyft, Restylane Silk, Perlane Galderma Laboratories L.P.
Fort Worth, TX 76177
Rebuild of the manufacturing line L3 clean rooms at Q-Med’s Facility 2 in Uppsala, Sweden.
P040036/S053
11/5/15
ThermoCool SmartTouch Ablation Catheter Biosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate location for a plasma etching process, in addition to the qualification of a newer equipment model for that same manufacturing process.
P040045/S052
11/17/15
VISTAKON (senofilcon A) Soft Contact Lens (spherical); VISTAKON (senofilcon A) Multifocal Soft Contact Lens; VISTAKON (senofilcon A) Toric Soft Contact Lens; VISTAKON (senofilcon A) Multifocal-Toric Soft Contact Lens; VISTAKON (senofilcon A) UV Blocking Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Implementation of an enhancement of injection molding machine (IMM) process conditions for the VISTAKON (senofilcon A) Brand Contact Lenses.
P060028/S015
11/20/15
Memoryshape Breast Implants Mentor Worldwide LLC.
Somerville, NJ 08876
Changes in the manufacturing process of the primary packaging equipment, and defect classification of the primary packaging visual inspection procedure.
P060037/S041
11/12/15
 
Zimmer Nexgen LPS-Flex Mobile and LPS Mobile Bearing Knee System Zimmer, Inc.
Warsaw, IN
46581
Addition of a new material supplier.
P060037/S042
11/23/15
Zimmer NexGen® LPS-Flex Mobile and LPS Mobile Bearing Knee System Zimmer, Incorporated
Warsaw, IN
46581
Addition of a new water generator.
P060040/S045
11/3/15
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA 94588
Modify the mold used to produce the HeartMate II Pocket Controller cases.
P080011/S039
11/6/15
Biofinity XR Toric CooperVision, Inc.
Pleasanton, CA 94588
Implementation of a new lathing process step in (Made to Order (MTO)) Production Line 1.
P080011/S040
11/6/15
Biofinity (comfilconA) Soft (hydrophilic) Contact Lenses CooperVision, Inc.
Pleasanton, CA 94588
Manufacturing change to modify the lens transfer process for the manufacture of the Biofinity (comfilcon A) toric contact lenses approved under the original PMA.
P080012/S032
11/24/15
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mount Olive, NJ 07828
Modify the manufacturing procedure for the Patient Therapy Controller (PTC) to reroute the PTC’s power cable within the assembly to prevent it from damage.  Additionally, update the final release test to add a “bolus test” to further verify the operation of the PTC prior to release.
P080025/S101
11/10/15
InterStim II Neurostimulator Medtronic Inc.
Minneapolis, MN 55432
Update of manufacturing process changes in the surface treatment of metal piece part for the impacted implatable products (i.e., titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.
P080025/S102
11/20/15
InterStim Therapy System Medtronic, Inc.
Minneapolis, MN 55432
Decreasing the frequency of Destructive Analysis (DA) sampling of Medium Rate batteries from once every 360/180 parts (approximately once per shift) to every 50 hours or 2400 parts ran, and the addition of FACTORYworks monitors for power and spot checks of the laser welds at Medtronic Energy and Component Center (Brooklyn Center, MN).
P090007/S013
11/24/15
Elecsys Anti-HCV Immunoassay and Elecsys PreciControl Anti-HCV for use on the cobas e 411 Immunoassay Analyzer Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P090008/S015
11/24/15
Elecsys Anti-HCV Immunoassay and Elecsys PreciControl Anti-HCV for use on the cobas e 601 and cobas e 602 Immunoassay Analyzers Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P090009/S013
11/24/15
Elecsys Anti-HCV Immunoassay and Elecsys PreciControl Anti-HCV for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P090013/S208
11/18/15
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN 55112
Changes to passivation process parameter settings and updates to sample sizes used for in process/final inspection at a supplier for several components of the subject lead.
P100010/S051
11/12/15
Freezor Max Cardiac CryoAblation Device, Arctic Front Cardiac CryoAblation Catheter, Arctic Front Advance Cardiac Cryoablation Catheter Medtronic Cryocath Lp
Quebec, Canada
H9R 5Z8
Changes to Smart Chip programming equipment and verification.
P100021/S050
11/24/15
Endurant Stent Graft System, Endurant II Stent Graft System Medtronic Vascular Inc.
Santa Rosa, CA 95403
Implementation of an in-process inspection using an automatic pick counter during the kitting process to inspect the picks per inch (PPI) of the recovered graft materials.
P100026/S038
11/5/15
Depth and Cortical Strip Leads for NeuroPace RNS System NeuroPace, Inc.
Mountain View, CA 94043
Use of an alternate epoxy adhesive (Epoxy Technology EPO-TEK 301 epoxy) during the manufacturing of a component for the depth and cortical strip leads.
P100031/S013
11/24/15
Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc for use on the cobas e 601, cobas e 602 and MODULAR ANALYTICS E170 Immunoassay Analyzers Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P100032/S010
11/24/15
Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc for use on the Elecsys 2010 and cobas e 411 Immunoassay Analyzers Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P100042/S009
11/9/15
Aptima HPV Hologic, Incorporated
San Diego, CA 92121
Addition of a vial filler for use in manufacturing and expansion of fill volume specifications.
P100047/S067
11/20/15
Heartware Ventricular Assist System Heartware, Inc.
Miami Lakes, FL 33014
Implementation of a visual inspection system for labels.
P110022/S014
11/24/15
Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Ant-HBc IgM on the cobas e 601 and cobas e 602 Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P110025/S012
11/24/15
Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM on the MODULAR ANALYTICS E170 Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P110031/S011
11/24/15
Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P110042/S053
11/4/15
Emblem Subcutaneous Implantable Debibrillator (S-ICD) Boston Scientific Corporation
St. Paul, MN
55112
Add an additional supplier for nickel foil used in the battery assembly.
P110042/S055
11/19/15
EMBLEM  S-ICD System Boston Scientific Corporation
St. Paul, MN
55112
Automation of the sterile packaging process.
P120002/S011
11/5/15
Cordis S.M.A.R.T. and S.M.A.R.T. Control Vascular Stent System Cordis Corporation
Fremont, CA
94555
Change to the manufacturing location of your supplier for the internal packaging pouches.
P120007/S007
11/9/15
Aptima HPV 16 18/45 Genotype Hologic, Incorporated
San Diego, CA 92121
Addition of a vial filler for use in manufacturing and expansion of fill volume specifications.
P120010/S073
11/18/15
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
Use a recently approved sensor base component on MPROC (Medtronic Puerto Rico Operation Company) Enlite sensors manufacturing line, to increase the number of components (bases and caps) treated per plasma cleaning cycle and to increase post-plasma shelf life of the treated components.  The Enlite Sensor is a component of the MiniMed 530G System.
P130015/S004
11/24/15
Elecsys HBeAg Immunoassay and Elecsys PreciControl HBeAg Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P140009/S006
11/6/15
Brio Neurostimulation System St. Jude Medical
Plano, TX
75024
Use an alternative batch test method for endotoxin monitoring for the Genesis/Eon/EonC/Eon Mini/Protégé/Brio families of devices.
P140009/S007
11/6/15
Brio Implantable Pulse Generators (IPGs) St. Jude Medical
Plano, TX
75024
Acceptance of the addition of an alternate supplier for the Implantable Pulse Generator (IPG) Weld Level sub-assemblies.
P140010/S011
11/23/15
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter Medtronic Vascular, Inc.
Santa Rosa, CA 95403
Use of an electronic system as an alternate to a paper-based system for determining and controlling Master Lot Records (MLRs) and sampling batches or MLRs for the purpose of lot release testing.
P140021/S001
11/24/15
Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV Roche Diagnostics
Indianapolis, IN 46250
Modification to an in-process testing procedure for the solid phase component used in the above listed Elecsys immunoassays.
P140028/S004
11/9/15
Innova Vascular Self Expanding Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Addition of equipment to your manufacturing process.
P140028/S005
11/16/15
Innova Vascular Self-Expanding Stent with Delivery System Boston Scientific Corporation
Maple Grove, MN 55311
Addition of equipment to your manufacturing process.
P140028/S006
11/30/15
Innova Vascular Self-Expanding Stent with Delivery System Boston Scientific
Maple Grove, MN 55311
Removal of stent outer diameter and length inspections for the Innova Stent System.

Summary of PMA Originals & Supplements Approved

  • Originals: 3
  • Supplements: 69

Summary of PMA Originals Under Review

  • Total Under Review: 57
  • Total Active: 30
  • Total On Hold: 27

Summary of PMA Supplements Under Review

  • Total Under Review: 583
  • Total Active: 433
  • Total On Hold: 150

Summary of All PMA Submissions

  • Originals: 4
  • Supplements: 75

Summary of PMA Supplement PMA Approval/Denial Decision Times

  • Number of Approvals: 69
  • Number of Denials: 0
  • Average Days Fr Receipt to Decision (Total Time): 193.4
  • FDA Time: 103.0 Days
  • MFR Time: 90.4 Days

Page Last Updated: 01/21/2016
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