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Medical Devices

December 2014 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
P140010
12/30/14
IN.PACT™ Admiral™ Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter Medtronic, Inc.
Santa Rosa, CA
95403
Approval for the IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter. This device is indicated for percutaneous transluminal angioplasty, after predilatation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.
P140020
12/19/14
BRACAnalysis CDx™ Myriad Genetic Laboratories, Inc.
Salt Lake City, UT 84108
Approval for the BRACAnalysis CDx. This device is indicated 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 eligible for treatment with Lynparz (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located Salt Lake City, Utah.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P830055/S150
12/8/14
180-Day
LCS® Total Knee System DePuy Orthopaedics, Incorporated
Warsaw, IN
46582
Approval for the addition of Tru-Match Pin Guides as compatible Components with the DePuy LCS® Total Knee System and the addition of Medical Modeling Incorporated as a manufacturing site for these components.
P830055/S152
12/31/14
Real-Time
LCS® Total Knee System DePuy Orthopaedics, Incorporated
Warsaw, IN
46582
Approval for the addition of a segmentation software package for use in the design of TruMatch® Resection Guides and Pin Guides.
P840001/S273
12/5/14
180-Day
ITREL 4 RESTORE SENSORY SURE SCAN MRT NEURO STIMULATION SYSTEMS Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for the changes to the Patient Programmer and Patient Recharge Kit used for Medtronic Spinal Cord Stimulation and Deep Brain Stimulation.
P850048/S038
12/23/14
135-Day
Access Hybritech PSA Assay Beckman Coulter, Inc.
Chaska, MN
55318
Approval for a change to the current reagent Real-Time stability test method for Access Reagent Packs, Calibrators and Samples Diluents to enhance the safety and reliability of the devices per 21 CFR 814.39(d)(2).
P880086/S248
12/22/14
Real-Time
Endurity Pacemakers St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for the addition of non-functional jumper connections for the hybrid assemblies utilized in the devices.
P880086/S249
12/11/14
Real-Time
Assurity, Assurity+, Endurity, Accent Family of Pacemakers St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home transmitters used with the devices.
P900056/S139
12/8/14
180-Day
Rotablator Rotational Angioplasty System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P910023/S346
12/11/14
Real-Time
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura,
Epic/Epic+, Atlas/II/+ family of ICDs Model EX2000 v8.0 Software for the Models EX1100 and EX1150
Merlin@home Transmitters
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home transmitters used with the devices.
P920047/S072
12/19/14
180-Day
Maestro 4000™ Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Approval for design changes, labeling changes, and a manufacturing site change of the Sterllartech Research Corporation from Sunnyvale, CA to Milpitas, CA for the Maestro 4000™ Cardiac Ablation System.
P920047/S073
12/8/14
180-Day
Blazer II Cardiac Ablation Catheter Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P930027/S016
12/3/14
135-Day
IMMULITE®/
IMMULITE® 1000, IMMULITE® 2000 PSA
Siemens Healthcare Diagnostics Products Ltd.
Gwynedd, UK
LL55 4EL
Approval for an additional assessment method by utilizing a panel of 10 normal male sera and a release panel of patient pools to maintain the performance of the device aligned to the WHO standard 96/670.
P950029/S099
12/15/14
Real-Time
Reply/Esprit SR/DR Pacemakers Sorin Group
Arvada, CO
80004
Approval for a modified desiccant and new battery insulator to be used in the final finished devices.
P950029/S101
12/23/14
Special
Reply and Esprit Family of Pacemakers Sorin CRM
Arvada, CO
80004
Approval for optimization of the gluing process for the silicone caps.
P960009/S197
12/5/14
180-Day
ACTIVA DEEP BRAIN STIMULATION SYSTEM Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for the changes to the Patient Programmer and Patient Recharge Kit used for Medtronic Spinal Cord Stimulation and Deep Brain Stimulation.
N970012/S099
12/8/14
135-Day
AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment American Medical Systems, Inc.
Minnetonka, MN 55343
Approval for use of different equipment by a vendor to quantify the level of antimicrobial active ingredient.
P970038/S027
12/23/14
135-Day
Access Hybritech free PSA Reagent /Calibrator Kit Beckman Coulter, Inc.
Chaska, MN
55318
Approval for a change to the current reagent Real-Time stability test method for Access Reagent Packs, Calibrators and Samples Diluents to enhance the safety and reliability of the devices per 21 CFR 814.39(d)(2).
P980003/S052
12/19/14
180-Day
Maestro 4000™ Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Approval for design changes, labeling changes, and a manufacturing site change of the Sterllartech Research Corporation from Sunnyvale, CA to Milpitas, CA forthe Maestro 4000™ Cardiac Ablation System.
P980003/S053
12/8/14
180-Day
Chilli II Cooled Ablation Catheter System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P980040/S049
12/17/14
180-Day
TECNIS® Multifocal 1-Piece Intraocular Lens Abbott Medical Optics Inc.
Santa Ana, CA 92705
Approval for the TECNIS® Multifocal 1-Piece Intraocular Lens, Models ZKB00 and ZLB00. This device is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.
P980041/S028
12/23/14
135-Day
Access AFP Immunoassay System Beckman Coulter, Inc.
Chaska, MN
55318
Approval for a change to the current reagent Real-Time stability test method for Access Reagent Packs, Calibrators and Samples Diluents to enhance the safety and reliability of the devices per 21 CFR 814.39(d)(2).
P000025/S078
12/8/14
MED-EL COMBI 40+ Cochlear Implant System MED-EL Corporation
Durham, NC
27713
Approval for the SONNET audio processor, MAESTRO 6.0 software, and RONDO WaterWear accessory.
P000053/S051
12/8/14
135-Day
AMS 800 Urinary Control System with InhibiZone Treatment American Medical Systems, Inc.
Minnetonka, MN 55343
Approval for use of different equipment by a vendor to quantify the level of antimicrobial active ingredient.
P010033/S025
12/5/14
180-Day
QuantiFERON®-TB Gold QIAGEN Incorporated
Gaithersburg, MD 20878
Approval for a manufacturing site located at QIAGEN in Germantown, Maryland.
P020009/S125
12/8/14
180-Day
Express 2 Monorail and Over-the-Wire Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P020012/S009
12/23/14
Panel-Track
Bellafill Suneva Medical, Inc.
Santa Barbara, CA
93111
Approval for the Bellafill. This device is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.
P020014/S042
12/11/14
180-Day
Essure System for Permanent Birth Control Bayer Healthcare, LLC
Milpitas, CA
95035
Approval of the post-approval study protocol.
P020025/S060
12/19/14
180-Day
Maestro 4000™ Cardiac Ablation System Boston Scientific Corporation
San Jose, CA
95134
Approval for design changes, labeling changes, and a manufacturing site change of the Sterllartech Research Corporation from Sunnyvale, California to Milpitas, California for the Maestro 400 Cardiac Ablation System.
P020025/S061
12/8/14
180-Day
Blazer II XP Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P020050/S017
12/17/14
180-Day
WaveLight® EX500 Laser System Alcon Laboratories, Inc.
Fort Worth, TX 76134
Approval for an alternate supplier for a camera sensor component of the Eyetracker camera for the WaveLight® EX500 Laser System.
P030008/S015
12/17/14
180-Day
WaveLight® EX500 Laser System Alcon Laboratories, Inc.
Fort Worth, TX 76134
Approval for an alternate supplier for a camera sensor component of the Eyetracker camera for the WaveLight® EX500 Laser System.
P030016/S027
12/22/14
180-Day
Visian Implantable Collamer Lens Staar Surgical Company
Monrovia, CA 91016
Approval to add new calculator software to the Visian Implantable Collamer Lens (ICL).
P030017/S202
12/19/14
180-Day
Precision® and Precision Spectra™ Spinal Cord Stimulation (SCS) Systems Boston Scientific Neuromodulation Valencia, CA
91355
Approval for the Precision M8 Adapter that will be used to connect the Precision Implantable Pulse Generator (IPG) or the Precision Spectra IPG to the following Medtronic (MDT) SCS Leads: Specify 2x8 Model 39286, Specify 5-6-5 Model 39565, lx8 Compact Model 3778, lx8 Standard Model 3777, lx8 Sub-Compact Model 3776, Test: lx8, Compact Model 3874, Test: lx8 Standard Model 3873, Test: lx8 Sub-Compact  Model 3875, Model 37081 Extension,  Model 37083 Extension, Model 37082 Extension, Vectris™ SureScan® MRI lx8 Subcompact, Model 977A160, 977A175, 977A190, and Vectris™ SureScan® MRI lx8 Compact, Model 977A260, 977A275, 977A290.
P030035/S126
12/22/14
Real-Time
Allure CRT-P and Allure Quadra
CRT-P
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for the addition of non-functional jumper connections for the hybrid assemblies utilized in the devices.
P030035/S127
12/11/14
Real-Time
Anthem, Allure/RF, Allure Quadra/RF Family of CRT-Ps St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home transmitters used with the devices.
P030054/S276
12/11/14
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 Model EX2000 v8.0 Software for the Models EX1100 and EX1150 Merlin@home transmitters used with the devices.
P040001/S021
12/12/14
180-Day
X-STOP® Interspinous Spacer System Medtronic Sofamor Danek USA, Incorporated
Memphis, TN 38132
Approval for an update to the X STOP® Interspinous Spacer System labeling to reflect the results from the Long Term Outcomes Study (LTOS) that was conducted as a postapproval study requirement.
P040002/S047
12/31/14
180-Day
AFX Endovascular Abdominal Aortic Aneurysm (AAA) Stent System Endologix, Inc.
Irvine, CA
92618
Approval for a manufacturing site located in Irvine, California.
P040016/S131
12/8/14
180-Day
VeriFLEX (Liberte) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P040024/S076
12/8/14
135-Day
Restylane, Restylane-L Perlane, and Perlane-L Injectable Gels Galderma Laboratories, L.P.
Fort Worth, TX 76177
Approval for the proposed introduction of an alternate bulk manufacturing room in the manufacturing process used in Factory 2 (F2) at the Q-Med facility in Uppsala, Sweden.
P040034/S024
12/11/14
180-Day
DuraSeal Dural Sealant System Integra LifeSciences Corporation
Burlington, MA 01803
Approval for a change to the Directions for Use (DFU) to expand the patient population to > 13 years of age.
P050044/S029
12/12/14
135-Day
Vitagel RT3 Surgical Hemostat Stryker Orthobiologics
Malvern, PA
19355
Approval for the relocation of certain manufacturing equipment used for assembly and packaging of Vitagel RT3 Surgical Hemostat from one room to another room within the firm’s Malvern, Pennsylvania facility.
P050047/S043
12/5/14
Special
JUVÉDERM Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Approval for strengthening the current warning and discussing the potential adverse reaction(s) associated with intravascular injection.
P060006/S062
12/8/14
180-Day
Express SD Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P070001/S012
12/22/14
135Day
ProDisc-C Total Disc DePuy Synthes Spine
Raynham, MA 02767
Approval for a change in manufacturing of the packaging.
P080006/S073
12/10/14
180-Day
Attain PerformaTM Left Ventricular Leads Medtronic, Inc.
Mounds View, MN 55112
Approval for the Attain PerformaTM Left Ventricular Leads (Models 4398 and 4598), indicated for chronic pacing in the left ventricle via the cardiac vein, when used with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system.
P080012/S022
12/18/14
180-Day
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mount Olive, NJ 07828
Approval for implementing a design change to incorporate a flow actuated safety valve (FAV) to the Prometra Pump.
P080030/S012
12/16/14
180-Day
Glaukos® Corporation iStent® Trabecular Micro-Bypass Stent System, Models GTS100R,
GTS100L (Stent Systems) and GTS100i (Stand-Alone Inserter)
Glaukos Corporation
Laguna Hills, CA 92653
Approval for the modifications to the Model GTS100i inserter and stent, which comprise the iStent Trabecular Micro-Bypass Stent System. The modifications include the following: 1) Changes to the inserter to include: a) A larger Sleeve diameter for increased rigidity of the Slide Assembly; b) An increase in the internal spring force; c) A change to the geometry and extension of the grasping tines on the end of the Slotted Tube; d) A re-design of the Release Button Rocker mechanism; and e) Color changes to two outer inserter components (rear housing and trigger button).  2) Changes to the stent to include:  a) An increase in the wall thickness of the snorkel by tightening the dimensional tolerance from a range 0.155 to 0.200 mm to a range of 0.170 to 0.200 mm; and b) Removal of the stenting height parameter from the finished device drawings 10-0018 and 10-0019 as a critical dimension. 3) Changes to the stent system to include: a) A change from sterilization following primary packaging to sterilization following final packaging; and b) Elimination of the in-process grip force testing step.
P090012/S005
12/19/14
135-Day
MelaFind MELA Sciences, Incorporated
Irvington, NY 10533
Transfer responsibility to perform integration of system (Cart assembly and hand-held imager) from MELA Sciences to a contract manufacturer
P090026/S012
12/23/14
135-Day
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for a change to the current reagent Real-Time stability test method for Access Reagent Packs, Calibrators and Samples Diluents to enhance the safety and reliability of the devices per 21 CFR 814.39(d)(2).
P100003/S005
12/18/14
180-Day
SECURE®-C Cervical Artificial Disc Globus Medical, Incorporated
Audubon, PA
19403
Approval for additional device sizes.
P100012/S006
12/19/14
180-Day
PCM® Cervical Disc System NuVasive, Incorporated
San Diego, CA 92121
Approval for a locking plate design modification, additional device sizes and Magnetic Resonance (MR) conditional labeling.
P100021/S044
12/19/14
Special
Endurant, Endurant II, Endurant IIs, and Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System Medtronic Inc.
Santa Rosa, CA 95403
Approval for the addition of a manufacturing aid during the hydrophilic coating process.
P100023/S102
12/8/14
180-Day
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P100023/S110
12/18/14
180-Day
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval of the post-approval study protocol.
P110010/S089
12/8/14
180-Day
PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Synergy Health in Alajuela, Costa Rica.
P110012/S007
12/10/14
Real-Time
Vysis ALK Break Apart FISH Probe Kit Abbott Molecular, Inc.
Des Plaines, IL 60016
Approval for modifications to the ProbeChk ALK Positive and Negative Control Slide labeling, and expansion of the assay guard band parameters.
P110013/S046
12/18/14
Real-Time
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Approval for a change in the shelf life for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System from 18 months to 24 months.
P120006/S013
12/18/14
135-Day
Ovation and Ovation Prime Abdominal Stent Graft System TriVascular, Inc.
Santa Rosa, CA 95403
Approval to change the manufacturing process for the ipsilateral tab on the aortic body stent graft from manual to automated.
P120014/S002
12/22/14
135-Day
THxID™ BRAF Kit BioMerieux, Inc.
Hazelwood, MO 63042
Approval for the following seven changes: Cleaning of dripping and spheres filling equipment, transfer of quality control activities into another room, raw material changes for bottles and caps for THxID-BRAF PUR, modification of a functional quality control (QC) test for the THxIDTM-BRAF PUR kit, transfer of buffer manufacturing (for the BRAF purification kit) into a new building at Qiagen, changes in DNase reference (AM2224) used in the determination of DNase activity in water and reagents, and shelf life extension for RNA transcripts and plasmids.
P130021/S008
12/10/14
Real-Time
Medtronic CoreValve® System Medtronic CoreValve LLC
Santa Rosa, CA 95403
Approval for the introduction of a revised cursor spring for the AccuTrak Delivery Catheter System (DCS).

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
P790007/S045
12/2/14
Hancock Modified Orifice Valved Conduit Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P810002/S091
12/15/14
Regent Mechanical Heart Valve, Standard and Masters Mechanical
Heart Valve
St. Jude Medical, Inc.
St Paul, MN
55117
Implementation of new proof tester units.
P810002/S092
12/18/14
St. Jude Medical Mechanical Heart Valves, St. Jude Medical Masters Series Mechanical Heart Valves,
St. Jude Medical Regent Heart Valves
St. Jude Medical, Inc.
St Paul, MN
55117
Addition of a new grinding machine for removal of excess pyrolytic coating.
P810006/S058
12/18/14
CollaStat Absorbable Collagen, Hemostatic Sponge
CollaStat Absorbable Collagen, Hemostatic Agent-Microfibrillar Form
Integra LifeSciences Corporation
Plainsboro, NJ 08536
Upgrade to the MicroFib Grinder blade for the devices.
P830055/S153
12/18/14
LCS Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Implement additional device identification measures.
P840001/S286
12/22/14
SCS Extensions,
SCS Leads 1x8 Family, and SCS Leads Pisces Family, SCS Leads Specify Family
Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Change the sampling strategy for the special manufacturing process monitoring.
P840064/S058
12/12/14
DUOVISC® Ophthalmic Viscosurgical Device, DISCOVISC® Ophthalmic Viscosurgical Device Alcon Research, Ltd.
Fort Worth, TX 76134
Addition of an alternate supplier for the 1 ml silicone barrels.
P850010/S057
12/18/14
HeliStat, Helitene Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation
Plainsboro, NJ 08536
Upgrade to the MicroFib Grinder blade for the devices.
P870076/S015
12/4/14
Disposable Falope-Ring Band Applicator Kits Gyrus ACMI, Inc.
Southborough, MA 01772
Adjustment of the sealing parameters and the repeat of a peel strength test and visual check.
P870078/S029
12/2/14
Hancock Low Porosity Valved Conduit Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P890003/S325
12/12/14
Prodigy IPG Medtronic CRDM
Mounds View, MN 55112
Modifications to the in-process battery inspection requirements for the batteries used in the  devices.
P890047/S045
12/12/14
PROVISC® Ophthalmic Viscosurgical Device Alcon Research, Ltd.
Fort Worth, TX 76134
Addition of an alternate supplier for the 1 ml silicone barrels.
P900009/S038
12/8/14
EXOGEN Ultrasound Bone Healing System Bioventus LLC.
Durham, NC
27703
Addition of a new servicing process.
P900056/S143
12/12/14
Rotablator® Rotational Angioplasty System Boston Scientific Corporation
Maple Grove, MN 55311
Addition of an alternate test method for the non-destructive pull tensile test for the RotaWire component.
P910001/S074
12/16/14
ELCA Coronary Atherectomy Catheters Spectranetics Corp.
Colorado Springs,  CO
80921
Remove repeated steps from the manufacturing process.
P910007/S046
12/11/14
ARCHITECT Total PSA Abbott Laboratories
Abbott Park, IL 60064
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices.
P910007/S047
12/8/14
ARCHITECT Total PSA Abbott Laboratories
Abbott Park, IL 60064
Replace an existing supplier with a new supplier for bovine serum albumin (BSA).
P910023/S349
12/15/14
Current Accel DR, Current Accel VR,
Current+ VR,
Current+ DR
St. Jude Medical
Sylmar, CA
91342
Alternate component attach material for the GMR component on hybrid assemblies for the devices.
P920047/S075
12/17/14
Blazer II, Blazer II HTD Temperature Ablation Catheters Boston Scientific Corporation
San Jose, CA
95134
Transfer of a device component production site.
P950005/S055
12/8/14
Celsius Flutters, Celsius, Celsius RMT, EZ Steer 4mm Non-Nav,
EZ Steer DS
Biosense Webster, Inc.
Diamond Bar, CA 91765
Additional supplier for extrusion and braiding processes.
P950029/S100
12/16/14
Reply SR, Reply DR, Esprit SR, Esprit DR Sorin CRM USA, Inc.
Arvada, CO
80004
Addition of a C-Mode Scanning Acoustic  Microscopy system in the manufacturing assembly line.
P950037/S145
12/3/14
DEXTRUS, SETROX S, TILDA, SAFIO S LEADS Biotronik, Inc.
Lake Oswega, OR 97035
Alternative assembly process for pacemaker leads.
P950039/S032
12/10/14
ThinPrep Processor 2000/3000 Hologic, Inc
Marlborough, MA 01752
Minor modification of the Liquid Crystal Display (LCD) circuit board used in the ThinPrep 2000 Processor display.
P960004/S067
12/11/14
FINELINE II Sterox Lead Boston Scientific Corporation
St. Paul, MN
55112
Modify the Hipot test specifications conducted during the Brady leads manufacturing.
P960009/S212
12/22/14
ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Change the sampling strategy for the special manufacturing process monitoring.
P960040/S338
12/19/14
ORIGEN, DYNAGEN, INOGEN, INCEPTA, ENERGEN, PUNCTUA Family of ICDs Boston Scientific Corporation
St. Paul, MN
55112
Changes to the crystal oscillator component manufacturing process at the current supplier.
P960040/S339
12/12/14
ORIGEN™ EL ICD, ORIGEN™ MINI ICD, DYNAGEN™ EL ICD, DYNAGEN™ MINI ICD, INOGEN™ EL ICD Boston Scientific Corporation
St. Paul, MN
55112
Modify the crystal oscillator manufacturing process at an existing supplier for the devices.
P960058/S113
12/12/14
HiResolution Bionic Ear System Advanced Bionics, LLC
Valencia, CA
91355
Relocate the ICS hybrid serialization process from the hybrid manufacturer to in-house hybrid serialization process at Advanced Bionics.
P970003/S175
12/17/14
VNS Therapy System Cyberonics, Inc.
Houston, TX
77058
Implementation of a new routing fixture.
P970004/S186
12/22/14
INTERSTIM  THERAPY SYSTEM Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Change the sampling strategy for the special manufacturing process monitoring.
P970021/S042
12/4/14
GYNECARE THERMACHOICE III Uterine Balloon Therapy System ETHICON, Inc.
Somerville, NJ 08876
Manufacturing changes to the GYNECARE THERMACHOICE II Controller to meet and comply with the European Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU by replacing non-RoHS compliant components with functionally equivalent RoHS compliant components.
P970031/S049
12/2/14
Freestyle Aortic Root Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P970051/S124
12/12/14
Cochlear Nucleus CI512 Implant System Cochlear Americas
Centennial, CO
80111
Update a misalignment between inspections conducted post-top shell fill molding and the silicone finishing inspection at subsequent operations.
P970051/S125
12/12/14
Cochlear Nucleus CI512 Implant System Cochlear Americas
Centennial, CO 80111
Update the electronic assembly inspection standard and align the electronic assembly inspection standard with the current inspection standards for the nucleus cochlear implant system.
P980003/S055
12/17/14
Chilli II Cooled Ablation Catheters Boston Scientific Corporation
San Jose, CA
95134
Transfer of a device component production site.
P980007/S037
12/11/14
ARCHITECT Free PSA Abbott Laboratories
Abbott Park, IL 60064
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices.
P980007/S038
12/8/14
ARCHITECT Free PSA Abbott Laboratories
Abbott Park, IL 60064
Replace an existing supplier with a new supplier for bovine serum albumin (BSA).
P980016/S509
12/4/14
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD Medtronic CRDM
Mounds View, MN 55112
Additional inspection step in the capacitor assembly epoxy process for the devices.
P980016/S510
12/12/14
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD,  Virtuoso II DR/VR ICD Medtronic CRDM
Mounds View, MN 55112
Update to the Pre-Pulse Open Circuit Test limits.
P980016/S511
12/19/14
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD Medtronic CRDM
Mounds View, MN 55112
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the  devices.
P980016/S512
12/19/14
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD Medtronic CRDM
Mounds View, MN 55112
New rework manufacturing process for the bonded anode subassembly used in the capacitors for the devices.
P980022/S164
12/4/14
Paradigm REAL‐ Time System,
Paradigm  REAL‐ Time Revel System,
Guardian Real‐Time  System,  MiniLink REAL‐Time System, iPro2 Professional Continuous Glucose Monitoring System
Medtronic, Inc.
Northridge, CA 91325
Implementation of five additional pieces of equipment at a contract manufacturer to support the manufacture of the lithium polymer batteries for the MiniLink REAL-Time Transmitter model number MMT-7703 and the iPro2 Digital Recorder model number MMT-7741. The MiniLink Transmitter is a component of the Paradigm REAL‐ Time System, Paradigm REAL‐ Time Revel System, Guardian Real‐Time System, MiniLink REAL‐Time System, as well as the MiniMed 530G System. The iPro2 Recorder is a component of the iPro2 Professional Continuous Glucose Monitoring System.
P980022/S170
12/3/14
Paradigm REAL-Time System
Paradigm REAL-Time Revel System
Medtronic MiniMed Inc.
Northridge, CA 91325
Change to a rejection criterion in the harvest of used motors during the manufacturing of refurbished pumps. The motor is a part of the insulin pump in the Paradigm REAL-Time System (MMT-522, MMT-722, MMT-522K, MMT-722K), the Paradigm REALTime Revel System (MMT-523, MMT-723, MMT-523K, MMT-723K), and the MiniMed 530G System (MMT-551, MMT-751).
P980022/S171
12/3/14
Paradigm REAL-Time System,
Paradigm REAL-Time Revel System,
Guardian REAL-Time CGM System,
MiniLink REAL-Time System,
iPro2 Professional CGM System
Medtronic MiniMed Inc.
Northridge, CA 91325
Change in the curing time during the manufacturing process for the Sen- Serter, which is a component of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, and iPro2 Professional CGM System.
P980022/S172
12/5/14
Paradigm Real-Time System,
Paradigm Real-Time Revel System,
Guardian REAL-Time System
Medtronic MiniMed Inc.
Northridge, CA 91325
Additional manufacturing testing to be performed on a previously approved component used in the manufacture of the Paradigm REAL-Time Insulin Pumps (MMT-522, MMT-522K, MMT-722, MMT-722K) and the Paradigm REAL-Time Revel Insulin Pumps (MMT-523, MMT-523K, MMT-723, MMT-723K) that are part of the Paradigm Real-Time System and the Paradigm Real-Time Revel System respectively. This component is also used in the Guardian REAL-Time Monitor (CSS7100, CS7100K) that is part of the Guardian REALTime System.
P980022/S173
12/19/14
Paradigm Real-Time System,
Paradigm Real-Time Revel System
Medtronic, Inc.
Northridge, CA 91325
Reprogramming of new PC boards/ stacks for the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), and MiniMed 530G Insulin Pump (Models: MMT-551, MMT-751) in Medtronic Puerto Rico Operations Co. (MPROC). The Paradigm REAL-Time Insulin Pump, Paradigm REAL-Time Revel Insulin Pump, and MiniMed 530G Insulin Pump are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, and MiniMed 530G System, respectively.
P980035/S401
12/12/14
Adapta, Versa, Sensia IPGs, Advisa DR IPG, Relia IPGs, Medtronic CRDM
Mounds View, MN 55112
Modifications to the in-process battery inspection requirements for the batteries used in the  devices.
P980035/S402
12/23/14
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, and Relia IPGs Medtronic, Inc.
Mounds View, MN 55112
New final functional tester for final device assembly manufacturing facilities.
P980035/S403
12/19/14
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG Medtronic CRDM
Mounds View, MN 55112
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the  devices.
P980040/S054
12/17/14
TECNIS® 1-Piece IOL with the TECNIS iTec Preloaded Delivery
System
Abbott Medical Optics, Inc.
Santa Anna, CA 92705
Alternate molding supplier for the lower body and protector cap components of the TECNIS iTec Preload Delivery System.
P980040/S055
12/31/14
TECNIS® 1-Piece IOL,  TECNIS® Multifocal 1-Piece IOL, TECNIS® Toric 1-Piece IOL,
SENSAR® 1-Piece IOL and TECNIS® OptiBlue® 1-Piece IOL
Abbott Medical Optics, Inc.
Santa Anna, CA 92705
Alternate supplier for an intraocular packaging component.
P980041/S031
12/8/14
Access AFP Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Modification to the Quality Control standard operations procedures for AFP prefill and postfill reagent pack.
P980043/S051
12/2/14
Hancock II Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P980044/S020
12/17/14
SUPARTZ Seikagaku Corporation
Tokyo, Japan
100-0005
Replace a previous autoclave with a new autoclave.
P980044/S021
12/17/14
SUPARTZ Seikagaku Corporation
Tokyo, Japan
100-0005
SPECTROPHOTOMETER SYSTEM T A007 FOR BACTERIAL ENDOTOXIN TESTING FOR BOTH IN PROCESS SAMPLES AND SUPARTZ
P980044/S022
12/17/14
SUPARTZ Seikagaku Corporation
Tokyo, Japan
100-0005
NEW TOTAL ORGANIC CARBON METER FOR SUPARTZ FINISHED DEVICE AT SKK-   TAKAHAGI FACILITY.
P980044/S023
12/17/14
SUPARTZ Seikagaku Corporation
Tokyo, Japan
100-0005
TWO NEW AUTOCLAVES FOR MICROBIOLOGICAL TESTING IN THE SSK-TAKAHAGI PLANT
P980049/S104
12/16/14
Paradym VR 8750, Paradym DR 8750, Paradym RF VR 9750, Paradym RF DR 9750, Paradym RF VR 9750, Paradum RF DR 9750, Intensia VR ICD, Intensia DR Sorin CRM USA, Inc.
Arvada, CO
80004
Addition of a C-Mode Scanning Acoustic  Microscopy system in the manufacturing assembly line.
P990012/S022
12/22/14
Elecsys® HBsAg Immunoassay, Elecsys® HBsAg PreciControl, and Elecsys® HBsAg Confirmatory Test Roche Diagnostics Corporation
Indianapolis, IN 46250
Relocation of the final kit assembly and labeling operations to a new building within the same facility.
P990025/S043
12/8/14
NAVISTAR ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc.
Diamond Bar, CA 91765
Additional supplier for extrusion and braiding processes.
P990064/S060
12/2/14
Mosaic Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine tissue supplier.
P990071/S030
12/12/14
SmartAblate System Biosense Webster, Inc.
Diamond Bar, CA 91765
Change to the assembler of the Printed Circuit Board Modules (PCB Modules) that are used in the SmartAblate System.
P990075/S030
12/15/14
Mentor SPECTRUM and Saline-Filled Breast Implants Mentor Worldwide LLC
Somerville, NJ 08876
Change to automate the existing silicone elastomer sheet cutter used to cut part components for Mentor Saline-Filled and SPECTRUM Breast Implants, Mentor MemoryGel Silicone Gel-Filled Breast Implants and Mentor MemoryShape Breast Implants manufactured at Mentor's Irving, Texas Facility.
P990075/S031
12/16/14
Mentor SPECTRUM and Saline-Filled Breast Implants Mentor Worldwide LLC
Santa Barbara, CA 93111
Change to automate the manual Secondary Packaging process to be used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor's Irving, Texas Facility.
P990081/S031
12/4/14
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Change in the manufacturing parameters for the Ventana reagent dispenser vent seal.
P000012/S050
12/4/14
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/
COBAS® AMPLICOR® HCV Test version 2.0
Roche Molecular Systems, Incorporated
Pleasanton, CA 94588
Discontinuation of an in-process QC test.
P000014/S028
12/11/14
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, VITROS Immunodiagnostic Products Anti-HBs Calibrators Ortho Clinical Diagnostics
Rochester, NY 14626
Removal of an upper test limit specification of a curve-shape parameter in an in-process quality control functionality test.
P000027/S020
12/22/14
Elecsys® Free PSA Immunoassay, Elecsys® Free PSA CalSet, and Elecsys® Free PSA CalCheck Roche Diagnostics Corporation
Indianapolis, IN 46250
Relocation of the final kit assembly and labeling operations to a new building within the same facility.
P000032/S042
12/18/14
Her Option Cryoablation Therapy System Cooper Surgical, Inc.
Trumbull, CT
06611
Change to the quality control high potential electrical safety analyzer from one device to another.
P010012/S378
12/12/14
DYNAGEN™ CRT-D, DYNAGEN™ X4 CRT-D, INOGEN™ CRT-D, INOGEN™ X4 CRT-D,   ORIGEN™ CRT-D,
ORIGEN™ X4 CRT-D, INCEPTA™ ICD,
ENERGEN™ ICD, PUNCTUA™ ICD
Boston Scientific Corporation
St. Paul, MN
55112
Modify the crystal oscillator manufacturing process at an existing supplier for the devices.
P010012/S379
12/19/14
ORIGEN, DYNAGEN, INOGEN, Family of CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Changes to the crystal oscillator component manufacturing process at the current supplier.
P010015/S254
12/19/14
Consulta CRT-P, Syncra CRT-P, Viva CRT-P Medtronic CRDM
Mounds View, MN 55112
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the  devices.
P010031/S473
12/4/14
Brava CRT-D, Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic CRDM
Mounds View, MN 55112
Additional inspection step in the capacitor assembly epoxy process for the devices.
P010031/S474
12/12/14
Concerto II CRT-D, Consulta CRT-D, Maximo II
CRT-D, Protecta CRT-D, Protecta XT CRT-D
Medtronic CRDM
Mounds View, MN 55112
Update to the Pre-Pulse Open Circuit Test limits.
P010031/S475
12/19/14
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic CRDM
Mounds View, MN 55112
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the  devices.
P010031/S476
12/19/14
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D Medtronic CRDM
Mounds View, MN 55112
New rework manufacturing process for the bonded anode subassembly used in the capacitors for the devices.
P010032/S088
12/19/14
Eon Implantable Pulse Generator,
EonC Implantable Pulse Generator,
Eon Mini Implantable Pulse Generator, Protégé Implantable Pulse Generator, Protégé MRI Implantable Pulse Generator
St. Jude Medical
Plano, TX
75024
Replace the AK-225 solvent used during the manufacturing process of the Implantable Pulse Generators.
P010032/S089
12/18/14
Tripole 16 Leads and Tripole 16C Lead, Exclaim Leads, Lamitrode 4 Lead, Lamitrode 44 Lead, Lamitrode 44C Lead, Lamitrode 88 Lead,
Lamitrode S-4 Leads, Lamitrode
S-8 Leads, Penta Leads, Octrode Leads, Quattrode Leads, A127 Lead Extension, Dual 4 Extension, Single 8 Extension, IS-1 Pocket Adapters,
8-Channel Adapters, M
St. Jude Medical
Plano, TX
75024
Implement manufacturing process changes.
P010033/S026
12/10/14
QuantiFERON®-TB Gold QIAGEN, Incorporated
Gaithersburg, MD 20878
Change to the manufacturing process for bulk peptide solutions.
P010054/S024
12/22/14
Elecsys® Anti-HBs Immunoassay, Elecsys® PreciControl Anti-HBs and Elecsys® Anti-HBs CalCheck Roche Diagnostics Corporation
Indianapolis, IN 46250
Relocation of the final kit assembly and labeling operations to a new building within the same facility.
P010068/S044
12/8/14
NaviStar DS, Celsius DS, EZ Steer Nav DS, NaviStar RMT DS, Celsius Flutters Biosense Webster, Inc.
Diamond Bar, CA 91765
Additional supplier for extrusion and braiding processes.
P020016/S007
12/9/14
Total Temporomandibular Joint Replacement System Biomet Microfixation
Jacksonville, FL 32218
Eliminate a step within the manufacturing process to remove the etch on the Titanium Mandibular, Cobalt Chrome mandibular and Fossa components
P020025/S065
12/17/14
Blazer II XP Temperature Ablation Catheters Boston Scientific Corporation
San Jose, CA
95134
Transfer of a device component production site.
P020055/S016
12/4/14
Pathway Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Change in the manufacturing parameters for the Ventana reagent dispenser vent seal.
P030002/S032
12/4/14
Crystalens, Trulign Toric Intraocular Lens Valeant Pharmaceuticals International, Incorporated
Irvine, CA
92688
Alternate cosmetic inspection process.
P030006/S027
12/16/14
Prolieve Thermodilatation System Medifocus Incorporated
Columbia, MD 21046
Change to replace the manual process of sanding the surface plates of the heat exchanger.
P030031/S064
12/8/14
NaviStar ThermoCool, Celsius ThermoCool, NaviStar RMT, ThermoCool, EZ Steer ThermoCool, Celsius RMT ThermoCool, ThermoCool SF, ThermoCool ST Biosense Webster, Inc.
Diamond Bar, CA 91765
Additional supplier for extrusion and braiding processes.
P030053/S021
12/15/14
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants Mentor Worldwide LLC
Somerville, NJ 08876
Change to automate the existing silicone elastomer sheet cutter used to cut part components for Mentor Saline-Filled and SPECTRUM Breast Implants, Mentor MemoryGel Silicone Gel-Filled Breast Implants and Mentor MemoryShape Breast Implants manufactured at Mentor's Irving, Texas Facility.
P030053/S022
12/16/14
Mentor MEMORYGEL Silicone Gel-Filled Breast Implants Mentor Worldwide LLC
Santa Barbara, CA 93111
Change to automate the manual Secondary Packaging process to be used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor's Irving, Texas Facility.
P030054/S279
12/15/14
Promote Accel, Promote+ St. Jude Medical
Sylmar, CA
91342
Alternate component attach material for the GMR component on hybrid assemblies for the devices.
P040043/S070
12/17/14
Gore TAG Thoracic Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Change to an in-process inspection step of the GORE TAG Thoracic Endoprosthesis manufacturing process.
P050042/S031
12/11/14
ARCHITECT Anti-HCV Abbott Laboratories
Abbott Park, IL 60064
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices.
P050051/S028
12/11/14
ARCHITECT AUSAB Abbott Laboratories
Abbott Park, IL 60064
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices.
P050051/S029
12/30/14
ARCHITECT AUSAB Abbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Change to discontinue redundant in-process QC tests for purified antibodies and antigens.
P060027/S071
12/16/14
Paradym CRT-D 8750, Paradym RF CRT-D 9750,
Paradym RF CRT-D 9750, Intensia
CRT-D
Sorin CRM USA, Inc.
Arvada, CO
80004
Addition of a C-Mode Scanning Acoustic  Microscopy system in the manufacturing assembly line.
P060028/S003
12/15/14
MEMORYSHAPE Breast Implants Mentor Worldwide LLC
Somerville, NJ 08876
Change to automate the existing silicone elastomer sheet cutter used to cut part components for Mentor Saline-Filled and SPECTRUM Breast Implants, Mentor MemoryGel Silicone Gel-Filled Breast Implants and Mentor MemoryShape Breast Implants manufactured at Mentor's Irving, Texas Facility.
P060028/S004
12/16/14
MEMORYSHAPE Breast Implants Mentor Worldwide LLC
Santa Barbara, CA 93111
Change to automate the manual Secondary Packaging process to be used in the production of MemoryShape, MemoryGel Silicone Gel-filled, Spectrum and Saline-filled Breast Implants manufactured at Mentor's Irving, Texas Facility.
P060033/S093
12/10/14
Endeavor Sprint Zotarolimus-Eiuting Coronary Stent System Medtronic
Santa Rosa, CA 95403
Option to sterilize using Cycle #3 on Lines 9 and 3, changing the Resolute Integrity’s pallet configuration, and co-sterilization of all similar DES devices (including those commercialized outside of US).
P060035/S024
12/11/14
ARCHITECT CORE-M Abbott Laboratories
Abbott Park, IL 60064
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices.
P060037/S033
12/30/14
NexGen LPS-Flex Mobile and LPS Mobile Bearing Knee Zimmer, Inc.
Warsaw, IN
46581
Change in the cleaning process.
P080011/S032
12/17/14
Biofinity (comfilcon A) extended‐wear, soft (hydrophilic) contact lenses CooperVision, Inc.
Pleasanton, CA 94588
Approval for the use of an alternate pick head material, for the manufacture of comfilcon A extended-wear contact lenses.
P080023/S026
12/11/14
ARCHITECT CORE Abbott Laboratories
Abbott Park, IL 60064
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices.
P080025/S082
12/22/14
INTERSTIM THERAPY SYSTEM Medtronic, Inc.
Neuromodulation
Minneapolis, MN 55432
Change the sampling strategy for the special manufacturing process monitoring.
P080026/S013
12/10/14
Abbott RealTime HBV Abbott Molecular, Incorporated
Des Plaines, IL 60018
Change to the equipment utilized for identity testing of oligonucleotides at the contract testing laboratory.
P080029/S002
12/18/14
Quick-close Vascular Suturing System Interventional Therapies, LLC.
Wilton, CT
06897
Change to the dimensional tolerances of the cannula and modifications to the bonding process for two device subassemblies.
P090013/S162
12/12/14
Revo MRI IPG Medtronic CRDM
Mounds View, MN 55112
Modifications to the in-process battery inspection requirements for the batteries used in the  devices.
P090013/S163
12/19/14
Revo MRI IPG Medtronic CRDM
Mounds View, MN 55112
New supplier for gold preform components that are used as brazing preforms in the manufacturing of feedthroughs for the  devices.
P100009/S008
12/17/14
MitraClip Delivery System Abbott Vascular, Inc.
Menlo Park, CA 94025
Changes related to the laser welding supplier and associated incoming inspections.
P100009/S009
12/22/14
MitraClip Delivery System Abbott Vascular, Inc.
Menlo Park, CA 94025
Implementation of an additional ethylene oxide sterilization chamber at the current sterilization facility.
P100017/S011
12/10/14
Abbott RealTime HCV Abbott Molecular, Incorporated
Des Plaines, IL 60018
Change to the equipment utilized for identity testing of oligonucleotides at the contract testing laboratory.
P100021/S043
12/19/14
Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II Aorto-Uni-Iliac Stent Graft System, Endurant IIs Stent Graft System Medtronic Inc.
Santa Rosa, CA 95403
Addition of new wire forming machines to the stent ring manufacturing line.
P100023/S111
12/18/14
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Add additional lines for the manufacture of the stent delivery catheter outer component at the Galway Ireland manufacturing facility.
P100024/S006
12/29/14
HER2 CISH pharmDx™ Kit Dako Denmark A/S
Glostrup, Denmark
2600
Modification of the quality control for incoming Alu-PNAs materials to reduce high background signal in the negative controls.
P100026/S025
12/22/14
Neuropace RNS System Neuropace, Inc.
Mountain View, CA 94053
Update the equipment software.
P100027/S020
12/4/14
INFORM HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc.
Tucson, AZ
85755
Change in the manufacturing parameters for the Ventana reagent dispenser vent seal.
P100029/S018
12/12/14
Trifecta™ Valve St. Jude Medical, Inc.
St. Paul, MN
55117
Alternate batch sampling/testing strategy for bacterial endotoxin testing (BET).
P100047/S051
12/4/14
HeartWare Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Automate various manufacturing processes.
P100047/S052
12/11/14
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Add a mechanized HVAD® housing gluing process for the HeartWare® Ventricular Assist System.
P100047/S054
12/19/14
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Add an alternate supplier for a component of the HeartWare Ventricular Assist System Pump.
P110002/S008
12/29/14
Mobi-C Cervical Disc Prosthesis LDR Spine USA, Inc.
Austin, TX
78750
Addition of a manufacturing machine and a cleaning process equipment change.
P110009/S008
12/29/14
Mobi-C Cervical Disc Prosthesis LDR Spine USA, Inc.
Austin, TX
78750
Addition of a manufacturing machine and a cleaning process equipment change.
P110010/S100
12/18/14
PROMUS Element™ Plus/ Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN 55311
Add additional lines for the manufacture of the stent delivery catheter outer component at the Galway Ireland manufacturing facility.
P110013/S047
12/10/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Option to sterilize using Cycle #3 on Lines 9 and 3, changing the Resolute Integrity’s pallet configuration, and co-sterilization of all similar DES devices (including those commercialized outside of US).
P110013/S048
12/16/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403
Modification to the test method used to determine the water content in the Zotarolimus drug.
P110023/S013
12/10/14
EverFlex Self-Expanding Peripheral Stent System ev3, Inc.
Plymouth, MN 55441
Change in the rinse solution for the pre-clean bath prior to electropolishing.
P110029/S018
12/11/14
ARCHITECT HBsAg Qualitative/ ARCHITECT HBsAg Qualitative Confirmatory Abbott Laboratories
Abbott Park, IL 60064
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices.
P110029/S019
12/17/14
ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory Abbott Laboratories
Abbott Park, IL 60064
Scale up the manufacturing batch size for the microparticle concentrates.
P110029/S020
12/30/14
ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory Abbott Laboratories, Diagnostics Division
Abbott Park, IL
60064
Change to discontinue redundant in-process QC tests for purified antibodies and antigens.
P110038/S008
12/12/14
Relay Thoracic Stent-graft With Plus Delivery System Bolton Medical, Inc.
Sunrise, FL
33325
Alternate supplier for medical grade polyvinyl chloride.
P120005/S030
12/12/14
Dexcom G4™ PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121
Manufacturing change in the layer application process for the G4 PLATINUM Sensor, which is a component of the Dexcom G4™ PLATINUM Continuous Glucose Monitoring System.
P120006/S018
12/18/14
Ovation and Ovation Prime Abdominal Stent Graft System Trivascular Inc.
Santa Rosa, CA 95403
Modifications to the equipment for stent graft loading.
P120008/S007
12/11/14
ARCHITECT AFP Abbott Laboratories
Abbott Park, IL 60064
Removal of a functional quality control test method that detects static charge in the ARCHITECT Reaction Vessel (RV) used in these devices.
P120010/S043
12/3/14
MiniMed 530G System Medtronic MiniMed Inc.
Northridge, CA 91325
Change to a rejection criterion in the harvest of used motors during the manufacturing of refurbished pumps. The motor is a part of the insulin pump in the Paradigm REAL-Time System (MMT-522, MMT-722, MMT-522K, MMT-722K), the Paradigm REALTime Revel System (MMT-523, MMT-723, MMT-523K, MMT-723K), and the MiniMed 530G System (MMT-551, MMT-751).
P120010/S045
12/14/14
Minimed 530G System Medtronic, Inc.
Northridge, CA 91325
Implementation of five additional pieces of equipment at a contract manufacturer to support the manufacture of the lithium polymer batteries for the MiniLink REAL-Time Transmitter model number MMT-7703 and the iPro2 Digital Recorder model number MMT-7741. The MiniLink Transmitter is a component of the Paradigm REAL‐ Time System, Paradigm REAL‐ Time Revel System, Guardian Real‐Time System, MiniLink REAL‐Time System, as well as the MiniMed 530G System. The iPro2 Recorder is a component of the iPro2 Professional Continuous Glucose Monitoring System.
P120010/S047
12/19/14
MiniMed 530G System Medtronic, Inc.
Northridge, CA 91325
Reprogramming of new PC boards/ stacks for the Paradigm REAL-Time Insulin Pump (Models: MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), and MiniMed 530G Insulin Pump (Models: MMT-551, MMT-751) in Medtronic Puerto Rico Operations Co. (MPROC). The Paradigm REAL-Time Insulin Pump, Paradigm REAL-Time Revel Insulin Pump, and MiniMed 530G Insulin Pump are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, and MiniMed 530G System, respectively.
P120010/S048
12/31/14
MiniMed 530G System Medtronic, Inc.
Northridge, CA
91325
Addition of the Medtronic Juncos Lab as a site for endotoxin testing for the Enlite Sensor that is part of the MiniMed 530G System.
P120012/S006
12/10/14
Abbott RealTime HCV Genotype II Abbott Molecular, Incorporated
Des Plaines, IL 60018
Change to the equipment utilized for identity testing of oligonucleotides at the contract testing laboratory.
P120022/S002
12/19/14
therascreen® EGFR RGQ PCR Kit QIAGEN
Manchester, United Kingdom
M15 6SH
Change to the manufacturing method of the Positive Control (PC) in the EGFR RGQ PCR kit. The change in manufacturing method includes an adjustment step of an in-process procedure to ensure that targeted amounts of each oligonucleotide within the PC are calculated to achieve the target crossing threshold (Ct).
P130009/S017
12/5/14
Novaflex + Delivery System, Edwards Expandable Introducer Sheath Set, Ascendra+ Delivery System, Ascendra+ Introducer Sheath Set Edwards Lifesciences, LLC.
Irvine, CA
92614
Implement an automated data analysis spreadsheet used during product verification testing.
P130009/S009
12/15/14
Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories Edwards Lifesciences LLC
Irvin, CA
92614
Change to the ink hardener used in the pad printing of graphics onto the NovaFlex+ Delivery System and the Edwards Expandable Introducer Sheath Set.
P130021/S009
12/15/14
Medtronic CoreValve System Medtronic CoreValve LLC
Santa Rosa, CA 95403
Modify the acceptance criteria for the parameters measured by the functional tester equipment.

Summary of PMA Originals & Supplements Approved

  • Originals: 2
  • Supplements: 60

Summary of PMA Originals Under Review

  • Total Under Review: 63
  • Total Active: 32
  • Total On Hold: 31

Summary of PMA Supplements Under Review

  • Total Under Review: 495
  • Total Active: 359
  • Total On Hold: 136

Summary of All PMA Submissions

  • Originals: 10
  • Supplements: 85

Summary of PMA Supplement PMA Approval/Denial Decision Times

  • Number of Approvals: 62
  • Number of Denials: 0
  • Average Days Fr Receipt to Decision (Total Time): 155.7 Days
  • FDA Time: 122.5 Days
  • MFR Time: 33.2 Days

 

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