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Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 53
Summary of PMA Originals Under Review
Total Under Review: 62
Total Active: 36
Total On Hold: 26
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 578
Total Active: 420
Total On Hold: 158
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 3
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 53
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 130.3
FDA Time: 86.9 Days MFR Time: 43.4 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P110007 7/2/12 |
Abbott Medical Optics, Inc. Healon® EndoCoat OpViscosurgical Opthalmic Device (OVD) (3% Sodium Hyaluronate) |
Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for the Abbott Medical Optics, Inc. Healon® EndoCoat OpViscosurgical Opthalmic Device (OVD) (3% Sodium Hyaluronate) is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment surgical procedures including, cataract surgery with an intraocular lens, cataract surgery without an intraocular lens, and secondary intraocular lens implantation. Healon® EndoCoat OVD maintains a deep chamber during anterior segment surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation. |
| P110030 7/6/12 |
therascreen®KRAS RGQ PCR Kit | QIAGEN Manchester Ltd. Manchester, United Kingdom M15 6SH |
Approval for the therascreen® KRAS RGQ PCR Kit. This device is indicated for: The therascreen® KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the RotorGene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene, using DNA extracted from formalin fixed paraffin-embedded (FFPE), colorectal cancer (CRC) tissue. The therascreen KRAS RGQ PCR Kit is intended to aid in the identification of CRC patients for treatment with Erbitux® (cetuximab) based on a KRAS no mutation detected test result. |
| P110037 7/5/12 |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for the CO BAS® AmpliPrep/COBAS® TaqMan® CMV Test. This device is indicated for: The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is anin vitro nucleic acid amplification test for the quantitative measurement of cytomegalovirus (CMV) DNA in human EDTA plasma using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test is intended for use as an aid in the management of solid-organ transplant patients who are undergoing anti-CMV therapy. In this population serial DNA measurements can be used to assess virological response to antiviral treatment. The results from the COBAS® AmpliPrep/ COBAS® TaqMan CMV Test must be interpreted within the context of all relevant clinical and laboratory findings. The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products. |
| P110043 7/31/12 |
Omnilink Elite Vascular Balloon- Expandable Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval for the Omnilink Elite Vascular Balloon-Expandable Stent System. This device is indicated for the treatment of atherosclerotic iliac artery lesions with reference vessel diameters of ≥ 5.0 mm and ≤ 11.0 mm and lesion lengths up to 50 mm. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810002/S082 7/25/12 135-Day |
Mechanical Heart Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for modifications to the Woodbridge Clean Access Environment. |
| P810025/S031 7/27/12 Special |
Amvisc® and Amvisc® Plus | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Approval for modifications to the directions for use to instruct the end-user to verify the connection of the cannula to the syringe luer. |
| P880006/S080 7/6/12 Real-Time |
Sensolog/Dialog/ Regency Family of Pulse Generators | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for an update to the Model 3330 Programmer Software from version 14.1 to 15.1. |
| P880086/S219 7/6/12 Real-Time |
Affinity/Integrity/ Victory/Zephyr/ Accent |
St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for an update to the Model 3330 Programmer Software from version 14.1 to 15.1. |
| P900061/S113 7/18/12 Real-Time |
Epicardial Patch Leads | Medtronic, Inc. Mounds View, MN 55112 |
Approval change in silicone tubing material used in the manufacturing of various cardiac leads as a result of discontinuation of the current material by an outside supplier. |
| P910001/S056 7/3/12 Real-Time |
CVX-300 Excimer Laser System | Spectranetics Corporation Colorado Springs, CO 80921 |
Approval for a change to the radio frequency (RF) absorption material for the CVX-300P model excimer laser. |
| P910023/S296 7/6/12 Real-Time |
Cadence/Ellipse/ Fortify Assura Family of ICDs | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for an update to the Model 3330 Programmer Software from version 14.1 to 15.1. |
| P920015/S090 7/18/12 Real-Time |
Transvene SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval to change in silicone tubing material used in the manufacturing of various cardiac leads as a result of discontinuation of the current material by an outside supplier. |
| P920015/S091 7/2/12 Real-Time |
Sprint Quattro Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a change to the currently approved Model 6935 Sprint Quattro Secure S lead which is a single defibrillation coil IS-1/DF-1 active fixation lead for the creation of a new Sprint Quattro Secure S single defibrillation coil DF4 active fixation lead, Model 6935M. |
| P930016/S035 7/17/12 180-Day |
STAR S4 IR Excimer Laser System with Variable Spot Scanning (VSS) | AMO Manufacturing USA, LLC Milpitas, CA 95035 |
Approval for Software Version 5.32. |
| P960040/S259 7/25/12 Real-Time |
Incepta, Energen, Punctua, Cognis and Teligen ICDs and CRT-D Pulse Generators | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an alternate supplier for the unfiltered feedthru. |
| P970003/S148 7/23/12 Real-Time |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval for the Model 250 Programming Software upgrade from version 8.0 to 8.1 and the addition of a new compact flashcard. |
| P970013/S049 7/6/12 Real-Time |
Microny Family of Pulse Generators | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for an update to the Model 3330 Programmer Software from version 14.1 to 15.1. |
| P970029/S020 7/26/12 Special |
TMR2000 Holmium Laser System | Cardiogenesis Kennesaw, GA 30144 |
Approval to add a warning to the outer box of the Sologrip III Handpiece. |
| P980016/S314 7/23/12 135-Day |
Maximo II, Protecta, Protecta XT, Secura and Virtuoso II ICDs | Medtronic, Inc. Mounds View, CA 55112 |
Approval for a change to the burn-in testing process for tantalum capacitors. |
| P980016/S364 7/25/12 Real-Time |
Concerto II/ Consulta/Maximo II/Protecta/Secura/ Virtuoso Family of CRT-Ds and ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an update to the L409 Integrated Circuit. |
| P980022/S100 7/6/12 Real-Time |
Paradigm REAL-Time Continuous Glucose Monitoring System, Paradigm REAL-Time Revel Continuous Glucose Monitoring System, Guardian REAL-Time Continuous Glucose Monitoring System, iPro Continuous Glucose Monitoring System, iPro2 Professional Continuous Glucose Monitoring System |
Medtronic, Inc. Northridge, CA 91325 |
Approval for an increase in battery lead wire length and tolerances, and increase wire stripping tolerances to match with the wire strip tool capabilities affecting the MiniLink Transmitter (MMT-7703), CGMS iPro Recorder (MMT-7709) and iPro2 Recorder (MMT-7741), which are components of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, iPro and iPro2 Professional Continuous Glucose Monitoring Systems. |
| P980022/S110 7/17/12 Real-Time |
Paradigm REAL-Time System, Guardian REAL-Time System, iPro2 Professional Continuous Glucose Monitoring (CGM) System | Medtronic, Inc. Northridge, CA 91325 |
Approval for language and pictorial changes to the Instructions for Use (IFU) of the Sof’-Sensor glucose sensor (MMT-7002) to make it consistent with the language that is included in the currently approved Paradigm REAL-Time Revel Insulin Pump and Paradigm REAL-Time Insulin Pump User Guides. The Sof-Sensor, Paradigm REAL-Time Revel Insulin Pump and Paradigm REAL-Time Insulin Pump are components of the Paradigm REAL- Time System, Guardian REAL-Time System, and iPro2 Professional Continuous Glucose Monitoring (CGM) System. |
| P980024/S008 7/16/12 Special |
PathVysion HER-2 DNA Probe Kit Assay | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for changes to PathVysion labeling in order to provide customers with consistent, current, and clear information. |
| P980035/S275 7/25/12 Real-Time |
Advisa DR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an update to the L409 Integrated Circuit. |
| P980050/S072 7/18/12 Real-Time |
Transvene Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval to change in silicone tubing material used in the manufacturing of various cardiac leads as a result of discontinuation of the current material by an outside supplier. |
| P990004/S022 7/18/12 Special |
SURGIFLO® Hemostatic Matrix and SURGIFLO® Hemostatic Matrix Kit with Thrombin | ETHICON, Incorporated Somerville, NJ 08876 |
Approval for a change in the wording of the Indication for Use Statement. Prior IFU: SURGIFLO® Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except ophthalmic) for hemostasis, when control of capillary, venous and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. New IFU: SURGIFLO® Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical. |
| P990009/S033 7/25/12 Real-Time |
Floseal Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Approval for the following changes to the Floseal Hemostatic Matrix 5ml kit configuration: modified bowl, pre-filled syringe of sodium chloride solution, and inclusion of a needle-free vial adapter. |
| P990009/S034 7/25/12 Real-Time |
Floseal Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Approval for the following changes to the Floseal Hemostatic Matrix 10ml kit configuration: inclusion of malleable tip; applicator; modified bowl; pre-filled syringe of sodium chloride solution; vial of thrombin (5000 units); and inclusion of a needle-free vial adapter. |
| P990065/S006 7/17/12 180-Day |
SIR-Spheres® Microspheres | Sirtex Medical Inc. Wilmington, MA 01887 |
Approval for a manufacturing site located at Sirtex Singapore Pte Ltd. in Singapore. |
| P000054/S033 7/17/12 Special |
INFUSE™ Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for modifications to the labeling for the identified products. Specifically requested the following: 1) an additional warning to address concerns related to the use of potential patients with a suspected malignancy; 2) an additional warning related to device migration; 3) a modification to the precaution related to ectopic, heterotopic and exuberant bone formation by removing the initial qualifying language; and 4) a modification to the description of the reconstituted recombinant protein solution, i.e., "…colorless to slightly yellow…" |
| P000058/S048 7/17/12 Special |
INFUSE™ Bone Graft/LT-Cage LumBar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for modifications to the labeling for the identified products. Specifically requested was the following: 1) an additional warning to address concerns related to the use of potential patients with a suspected malignancy; 2) an additional warning related to device migration; 3) a modification to the precaution related to ectopic, heterotopic and exuberant bone formation by removing the initial qualifying language; and 4) a modification to the description of the reconstituted recombinant protein solution, i.e., "…colorless to slightly yellow…" |
| P010012/S289 7/25/12 Real-Time |
Incepta, Energen, Punctua, Cognis and Teligen ICDs and CRT-D Pulse Generators | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an alternate supplier for the unfiltered feedthrough. |
| P010014/S035 7/19/12 Special |
Oxford® Partial Knee System | Biomet Manufacturing Corporation Warsaw, IN 46581 |
Approval for changes to the surgical technique manual. |
| P010015/S164 7/25/12 Real-Time |
Consulta/Syncra Family of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an update to the L409 Integrated Circuit. |
| P010030/S032 7/13/12 Real-Time |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval for 2 mechanical design modifications to the method of attaching the hook component of the hook and loop fasteners to the ECG electrode housing. |
| P010030/S034 7/25/12 Real-Time |
LifeVest Wearable Defibrillator | Zoll Lifecor Corporation Pittsburgh, PA 15238 |
Approval for a change of plating material from tin to gold on the following components: 1) board-to-board connectors on the Computer board and High Voltage Board; 2) 12-position jumper; and 3) board-to-board connectors on the computer, bedside, and battery connector boards. |
| P010031/S268 7/23/12 135-Day |
Concerto II, Consulta, Maximo II, Protecta and Protecta XT CRT-Ds and ICDs |
Medtronic, Inc. Mounds View, CA 55112 |
Approval for a change to the burn-in testing process for tantalum capacitors. |
| P010031/S316 7/25/12 Real-Time |
Concerto II/ Consulta/ Maximo II/ Protecta/Secura/ Virtuoso Family of CRT-Ds and ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Approval for an update to the L409 Integrated Circuit. |
| P010032/S053 7/31/12 Real-Time |
Genesis and Eon Neurostimulators | St. Jude Medical Plano, Texas 75024 |
Approval for upgrading the Rapid Programmer software used in the Genesis and Eon family neuromodulation stimulators from version 3.3 (Model 3831 and 3832) to version 3.4 (Model 3834). |
| P010032/S054 7/12/12 Real-Time |
Eon 16-channel Implantable Pulse Generators (IPG) Neurostimulation | St. Jude Medical Plano, TX 75024 |
Approval to reverse the gender of the contacts of the plug and receptacle on the portable Charger (models 3711 and 3715) i.e., a receptacle for connecting the charging antenna will now have female pins for contacts, while the mating plug on the charging antenna will now have male contacts. Additionally, it was requested to change the pin-out connector from a 3 pin version to a 4 pin version. |
| P020018/S039 7/17/12 180-Day |
Zenith Renu AAA Ancillary Graft | Cook, Inc. Bloomington, IN 47402 |
Approval for a modified label to incorporate information from the post-approval study. |
| P020018/S045 7/26/12 Special |
Zenith Fenestrated® AAA Endovascular Graft | Cook, Inc. Bloomington, IN 47402 |
Approval for changes to the Instructions for Use for the device. |
| P030011/S013 7/5/12 Real-Time |
SynCardia Companion 2 Driver System | SynCardia Systems, Inc. Tucson, AZ 85713 |
Approval for software changes to the device. |
| P030035/S097 7/6/12 Real-Time |
Frontier/Frontier II/ Anthem Family of CRT-Ps | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for an update to the Model 3330 Programmer Software from version 14.1 to 15.1. |
| P030054/S224 7/6/12 Real-Time |
Epic HF/Atlas+ HF/ Quadra Assura/ Unify Assura Family of CRT-Ds | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Approval for an update to the Model 3330 Programmer Software from version 14.1 to 15.1. |
| P040001/S020 7/25/12 180-Day |
X-STOP Interspinous Spacer System | Medtronic, Inc. Memphis, TN 38132 |
Approval for a manufacturing site located at Medtronic Sofamor Danek USA, Inc. in Memphis, Tennessee. |
| P040038/S024 7/24/12 180-Day |
Xact® Carotid Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Approval for the addition of the PROTECT Post-Approval Study (PAS) results to the Instructions for Use (IFU). |
| P050010/S012 7/10/12 Real-Time |
ProDisc-L™ Total Disc Replacement | Synthes Spine, Inc. West Chester, PA 19380 |
Approval of a protocol for extension of shelf- life for the polyethylene inlay component from three (3) years to five (5) years. |
| P050012/S039 7/24/12 135-Day |
Dexcom™ SEVEN and SEVEN PLUS® Continuous Glucose Monitoring Systems | Dexcom, Inc. San Diego, CA 92121 |
Approval for a proposed change to remove redundant destructive testing for bond strength of three applicator components (cannula carrier, push rod carrier, and sensor needle carrier) of the devices. |
| P050028/S015 7/12/12 135-Day |
COBAS® TaqMan® HBV Test for use with The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a change in the manufacturing process of bulk CapG GNR wash reagent. |
| P060011/S004 7/17/12 Real-Time |
C-flex™ Aspheric Intraocular Lens | Rayner Intraocular Lenses Limited East Sussex, England BN3 7AN |
Approval for the addition of an aspheric optical surface to the anterior surface of the parent C-flex™ Intraocular Lens Model 570C (Power range +8.0 to + 17.5 D). |
| P060019/S021 7/10/12 Real-Time |
Safire BLU SP Ablation Catheter, Therapy Cool Path SP (bi-directional) Ablation Catheter | St. Jude Medical Company Irvine, CA 92614 |
Approval for an alternative package configuration for the subject ablation catheters. The new package configuration would change the previous coiled tray configuration to a tray with a straight configuration. The device, as modified, will be marketed under the trade names Safire BLU SP Irrigated Ablation Catheter, Therapy Cool Path SP (Bi-directional) Ablation Catheter, and Safire BLU™ DUO SP Ablation Catheter. |
| P060030/S016 7/12/12 135-Day |
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and COBAS® TaqMan® HCV Test version 2.0 for use with The High Pure System |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a change in the manufacturing process of bulk CapG GNR wash reagent. |
| P060033/S069 7/31/12 180-Day |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for changes to the instructions for use (with the latest available follow-up clinical data from the Endeavor clinical trial programs). |
| P060040/S022 7/5/12 Real-Time |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Approval for changes to the HeartMate II Left Ventricular Assist System (LVAS) regarding discontinuation of the Emergency Power Pack (EPP) and some minor labeling modifications. |
| P080004/S012 7/17/12 Real-Time |
iSert® Intraocular Lens (IOL) | Hoya Surgical Optics Chino Hills, CA 91709 |
Approval for a packaging configuration change for the iSert® Model PC-60AD Intraocular Lens (IOL). The device, as modified, will be marketed under the trade name iSert® Model 230 and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. |
| P110016/S002 7/10/12 Real-Time |
Safire BLU DUO SP Ablation Catheters | St. Jude Medical Company Irvine, CA 92614 |
Approval for an alternative package configuration for the subject ablation catheters. The new package configuration would change the previous coiled tray configuration to a tray with a straight configuration. The device, as modified, will be marketed under the trade names Safire BLU SP Irrigated Ablation Catheter, Therapy Cool Path SP (Bi-directional) Ablation Catheter, and Safire BLU™ DUO SP Ablation Catheter. |
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 |
|---|---|---|---|
| N18-033/S066 7/30/12 |
VISTAKON (etafilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Addition of an automated quality control inspection step. |
| P810002/S083 7/26/12 |
St. Jude Medical Mechanical Heart Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Removal of the line scan lot release test. |
| P810025/S032 7/27/12 |
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device | Bausch & Lomb Aliso Viejo, CA 92656 |
Change to use an automated assembly, inspection and packaging system during manufacturing. |
| P820021/S034 7/30/12 |
Vifilcon A Soft Contact Lenses for Extended Wear | CIBA VISION Corporation Duluth, GA 30097 |
Change in raw material test method. |
| P830061/S076 7/5/12 |
CapSure, Vitatron Crystalline, Vitatron Excellence PS+ | Medtronic CDRM Mounds View, MN 55112 |
Additional supplier for the vein lifter component. |
| P840064/S051 7/23/12 |
DUOVISC Ophthalmic Viscosurgical Devices | Alcon Research, Inc. Fort Worth, TX 76134 |
Alternate component supplier. |
| P850079/S053 7/11/12 |
methafilcon A and methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Addition of duplicate microbiological manufacturing equipment. |
| P850089/S088 6/5/12 |
CapSure Z Novus Leads, CapSure SP Novus Leads, CapSure SP Z Leads, CapSure Z Novus Leads, Impulse II Leads | Medtronic CDRM Mounds View, MN 55112 |
Additional supplier for the vein lifter component. |
| P860008/S022 7/18/12 |
Tapscope 550, Tapcath 205 Transesophageal Cardiac Stimulators | Cardiocommand, Inc. Tampa, FL 33507 |
Addition of a new piece of equipment used to cut and strip pacing wires and shrink tubing. |
| P860047/S026 7/31/12 |
OcuCoat Ophthalmic Viscosurgical Device (OVD) | Bausch & Lomb Aliso Viejo, CA 92656 |
Change to use an automated assembly, inspection and packaging system during manufacturing. |
| P860057/S090 7/11/12 |
Carpentier-Edwards PERIMOUNT Pericardial Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
An increase in the number of HEPA filters in a gowning room and the addition of corresponding hand dryers, and remodeling of a transfer room to include an emergency exit corridor and emergency exit door. |
| P870056/S050 7/11/12 |
Carpentier-Edwards Porcine Aortic and Mitral Valve Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
An increase in the number of HEPA filters in a gowning room and the addition of corresponding hand dryers, and remodeling of a transfer room to include an emergency exit corridor and emergency exit door. |
| P870076/S012 7/5/12 |
Disposable Falope-Ring Band Applicator Kits | Gyrus ACMI, Inc. Southborough, MA 01772 |
Change in the quality control method used during the tray and pouch manufacturing process. |
| P870077/S045 7/11/12 |
Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis; Carpentier –Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture Ring | Edwards Lifesciences LLC Irvine, CA 92614 |
An increase in the number of HEPA filters in a gowning room and the addition of corresponding hand dryers, and remodeling of a transfer room to include an emergency exit corridor and emergency exit door. |
| P890003/S250 7/5/12 |
CapSure, CapSure Model | Medtronic CDRM Mounds View, MN 55112 |
Additional supplier for the vein lifter component. |
| P890047/S039 7/23/12 |
PROVISC Ophthalmic Viscosurgical Devices | Alcon Research, Inc. Fort Worth, TX 76134 |
Alternate component supplier. |
| P900056/S116 7/6/12 |
Rotablator Rotational Atherectomy System | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of an in-process pull test and introduction of a start of shift equipment verification. |
| P910001/S057 7/6/12 |
CVX-300 Laser System | Spectranetics Corporation Colorado Springs, CO 80921 |
Addition of a component supplier for the device. |
| P910001/S058 7/25/12 |
ELCA Coronary Atherectomy Catheters | Spectranetics Corporation Colorado Springs, CO 80921 |
Addition of new extrusion equipment. |
| P910001/S060 7/31/12 |
ELCA Coronary Atherectomy Catheters | Spectranetics Corporation Colorado Springs, CO 80921 |
Changes to the On-Demand Label Printing System. |
| P910073/S103 7/13/12 |
Endotak Lead System | Boston Scientific –CRM St. Paul, MN 55112 |
Add an alternate supplier for lead components. |
| P910073/S104 7/12/12 |
Endotak Reliance Ez IS-1 Active Fixation Lead, Endotak Reliance Ez Quadripolar (DF4) Active Fixation Lead | Boston Scientific CRM St. Paul, MN 55112 |
Additional supplier for a lead tip component. |
| P920015/S092 7/5/12 |
Sprint Quattro, Sprint Quattro Lead, Transvene SVC Lead | Medtronic CDRM Mounds View, MN 55112 |
Additional supplier for the vein lifter component. |
| P930031/S032 7/11/12 |
Wallstent (Tips) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Critical component supplier site change. |
| P930031/S033 7/12/12 |
Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the firm’s ethylene oxide sterilization cycles. |
| P930039/S068 7/5/12 |
CapSureFix Lead, CapSure Fix Novus Lead, SureFix Lead, Vitatron Crystalline Leads | Medtronic CDRM Mounds View, MN 55112 |
Additional supplier for the vein lifter component. |
| P940019/S027 7/11/12 |
Wallstent (Iliac) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Critical component supplier site change. |
| P940019/S028 7/12/12 |
Wallstent (Iliac) Endoprosthesis with Unistep Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the firm’s ethylene oxide sterilization cycles. |
| P950005/S039 7/25/12 |
Celsius Diagnostic/ Ablation Deflectable Tip Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Alternate supplier of the conductor cable component. |
| P950020/S051 7/11/12 |
Flextome Cutting Balloon | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the location of a critical component supplier. |
| P950029/S069 7/30/12 |
Reply SR and DR, Esprit SR and DR | Sorin CRM USA, Inc. Plymouth, MN 55441 |
Moved component assembly step, removal of an optional cleaning step and alternative component attachment inspection equipment. |
| P950029/S070 7/31/12 |
Reply/Esprit Pacemaker | Sorin CRM, Inc. Plymouth, MN 55441 |
Update to the thermosealing process. |
| P960004/S052 7/18/12 |
FineLine Pacing Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a current cleaning step. |
| P960006/S034 7/12/12 |
Flextend Bipolar, Steroid Eluting, Extendable/ Retractable Pacing Leads | Boston Scientific CRM St. Paul, MN 55112 |
Additional supplier for a lead tip component. |
| P960040/S264 7/3/12 |
Incepta, Energen, Punctua and Teligen ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of the alternate suppliers for various electrical components. |
| P960042/S039 7/25/12 |
SLS (Spectranetics Laser Sheaths) | Spectranetics Corporation Colorado Springs, CO 80921 |
Addition of new extrusion equipment. |
| P960042/S040 7/31/12 |
SLS (Spectranetics Laser Sheaths) | Spectranetics Corporation Colorado Springs, CO 80921 |
Changes to the On-Demand Label Printing System. |
| P970003/S150 7/26/12 |
VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 |
Updates to the Electrical Test System software for various models of the VNS Therapy® System Pulse Generators. |
| P980033/S021 7/11/12 |
Wallstent (Venous) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Critical component supplier site change. |
| P980033/S22 7/12/12 |
Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the firm’s ethylene oxide sterilization cycles. |
| P980035/S273 7/5/12 |
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Updates to the integrated circuit test solution. |
| P980035/S274 7/11/12 |
Adapta, Relia and Versa IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the Automated Accelerometer Test System software. |
| P980035/S276 7/26/12 |
Advisa DR IPG, EnRhythm IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an in-process inspection of the hybrid cathode mix ratio. |
| P980049/S075 7/30/12 |
Paradym VR, DR, RF, VR and RF DR | Sorin CRM USA, Inc. Plymouth, MN 55441 |
Moved component assembly step, removal of an optional cleaning step and alternative component attachment inspection equipment. |
| P980049/S076 7/31/12 |
Paradym VR/DR, Paradym RF VR/DR ICD | Sorin CRM, Inc. Plymouth, MN 55441 |
Update to the thermosealing process. |
| P980050/S074 7/5/12 |
Transvene Lead | Medtronic CDRM Mounds View, MN 55112 |
Additional supplier for the vein lifter component. |
| P990025/S033 7/25/12 |
Navistar Ablation Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Alternate supplier of the conductor cable component. |
| P990071/S019 7/25/12 |
Stockert RF Generator | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Alternate supplier of the conductor cable component. |
| P990074/S024 7/23/12 |
Natrelle Saline-Filled Breast Implants | Allergan Goleta, CA 93117 |
Addition of a step to the incoming inspection procedures for the raw materials used in the manufacture of the device. |
| P000007/S032 7/11/12 |
Edwards Prima Plus Stentless Porcine Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
An increase in the number of HEPA filters in a gowning room and the addition of corresponding hand dryers, and remodeling of a transfer room to include an emergency exit corridor and emergency exit door. |
| P000020/S015 7/12/12 |
Stinger, Stinger S, Stinger M, Stinger SM, Scorpion *2, Scorpion *2M Ablation Catheters | C.R. Bard, Inc. Lowell, MA 01851 |
Additional supplier of electrode extension cables. |
| P000036/S012 7/5/12 |
Dermagraft | Advanced BioHealing, Inc. LaJolla, CA 92037 |
Relocation of the Quality Control laboratories from a temporary location to the renovated laboratory within the current manufacturing facility. |
| P000036/S013 7/23/12 |
Dermagraft Human Fibroblast | Advanced BioHealing, Inc. LaJolla, CA 92037 |
Usage of two additional vacuum sealers during the packaging process. |
| P000037/S027 7/11/12 |
On-X Prosthetic Heart Valve | On-X Technologies, Inc. Austin, TX 78752 |
Change in receiving acceptance testing. |
| P010012/S294 7/3/12 |
Incepta, Energen, Punctua and Cognis CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of the alternate suppliers for various electrical components. |
| P010015/S165 7/26/12 |
Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 5112 |
Addition of an in-process inspection of the hybrid cathode mix ratio. |
| P010041/S034 7/11/12 |
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 |
An increase in the number of HEPA filters in a gowning room and the addition of corresponding hand dryers, and remodeling of a transfer room to include an emergency exit corridor and emergency exit door. |
| P010068/S029 7/25/12 |
Navistar and Celsius DS Ablation Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Alternate supplier of the conductor cable component. |
| P020009/S086 7/6/12 |
Express 2 Coronary Stent Systems | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of new software to interface with the Manufacturing Execution System (MES). |
| P020009/S087 7/26/12 |
Express 2 Coronary Stent Systems | Boston Scientific Corporation Maple Grove, MN 55311 |
Software modification to the balloon stretching process. |
| P020009/S089 7/25/12 |
Express 2 Coronary Stent Systems | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a cooling fixture to the hot jaw process. |
| P020055/S003 7/24/12 |
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Addition of a supplier of raw materials for the iView Detection kit, which is part of the device. |
| P020056/S017 7/18/12 |
Natrelle Silicone-Filled Breast Implants | Allergan Goleta, CA 93117 |
Addition of an incoming verification step for silicone elastomer raw materials metals testing. |
| P030017/S136 7/10/12 |
Precision® Spinal Cord Stimulation (SCS) System | Boston Scientific Corporation Valencia, CA 91355 |
Clarify visual inspection criteria for the Paddle Disk. |
| P030017/S137 7/17/12 |
Precision® Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Valencia, CA 91355 |
Use of a modified gross lead detection method for the Implantable Pulse Generator (IPG). |
| P030017/S138 7/24/12 |
Precision Spinal Cord Stimulation System | Boston Scientific Corporation Valencia, CA 91355 |
Alternate qualified supplier for electrodes and contacts. |
| P030025/S098 7/6/12 |
TAXUS Express Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of new software to interface with the Manufacturing Execution System (MES). |
| P030031/S043 7/23/12 |
Celsius ThermoCool Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Addition of a packaging component. |
| P030036/S043 7/5/12 |
SelectSecure Lead | Medtronic CDRM Mounds View, MN 55112 |
Additional supplier for the vein lifter component. |
| P030036/S044 7/18/12 |
SelectSecure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of a new physical vapor deposition system. |
| P040005/S008 7/31/12 |
HER2 FISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Manufacturing process of PNA oligomers in the device. |
| P040012/S047 7/11/12 |
Acculink Carotid Stent System | Abbott Vascular Temecula, CA 92590 |
Align clean room alert limits with a new standard. |
| P040012/S048 7/11/12 |
Acculink Carotid Stent System | Abbott Vascular Temecula, CA 92589 |
Change to sample size for pyrogen testing. |
| P040016/S089 7/11/12 |
VeriFLEX Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the location of a critical component supplier. |
| P040016/S090 7/26/12 |
VeriFLEX (Libertè) Bare-Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software modification to the balloon stretching process. |
| P040016/S092 7/25/12 |
VeriFLEX Monorail & Over-the-Wire Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a cooling fixture to the hot jaw process. |
| P040024/S060 7/26/12 |
Restylane Injectable Gel | Medicis Aesthetics Scottsdale, AZ 85256 |
Change in the particle size processing (PSR) during Restylane L manufacture. |
| P040038/S026 7/11/12 |
ACT Carotid Stent System | Abbott Vascular Temecula, CA 92590 |
Align clean room alert limits with a new standard. |
| P040038/S027 7/11/12 |
Xact Carotid Stent System | Abbott Vascular Temecula, CA 92589 |
Change to sample size for pyrogen testing. |
| P040045/S033 7/30/12 |
VISTAKON (senofilcon B) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Addition of an automated quality control inspection step. |
| P050007/S030 7/11/12 |
Starclose SE Vascular Closure System | Abbott Vascular Redwood City, CA 94063 |
Gas change for a welding step. |
| P050019/S009 7/11/12 |
Wallstent (Carotid) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Critical component supplier site change. |
| P050040/S003 7/6/12 |
SPOT-Light® HER2 CISH™ Kit | Life Technologies, Inc. Frederick, MD 21704 |
Extension of the expiration date for a single lot of HER-2 SPT DNA template ( Lot 63013). |
| P050042/S017 7/31/12 |
ARCHITECT Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 |
Change to use new containers for manufacturing of microparticle based components and implementing a new test to verify the effectiveness of the preventive action. |
| P050047/S027 7/23/12 |
Juvèderm Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
New test release specification for Juvèderm Ultra XC and Juvèderm Ultra Plus XC 1.0 ml syringes. |
| P060006/S029 7/6/12 |
Express SD Renal Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of new software to interface with the Manufacturing Execution System (MES). |
| P060007/S018 7/3/12 |
ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Change to the quality control method used for anti-HBs testing for incoming human plasma units. |
| P060008/S089 7/6/12 |
TAXUS Liberte Express Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of new software to interface with the Manufacturing Execution System (MES). |
| P060008/S090 7/11/12 |
TAXUS Liberte Express Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the location of a critical component supplier. |
| P060008/S091 7/26/12 |
TAXUS Liberte Express Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software modification to the balloon stretching process. |
| P060008/S092 7/25/12 |
TAXUS Liberte Express Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a cooling fixture to the hot jaw process. |
| P060027/S043 7/30/12 |
Paradym CRT-D, RF CRT-D | Sorin CRM USA, Inc. Plymouth, MN 55441 |
Moved component assembly step, removal of an optional cleaning step and alternative component attachment inspection equipment. |
| P060027/S044 7/31/12 |
Paradym CRT-D, Paradym RF CRT-D | Sorin CRM, Inc. Plymouth, MN 55441 |
Update to the thermosealing process. |
| P060038/S014 7/25/12 |
Mitroflow Aortic Pericardial Heart Valve | Sorin Group USA, Inc. Arvada, CO 80004 |
Additional bovine pericardium tissue supplier. |
| P070015/S096 7/11/12 |
XIENCE V Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92590 |
Align clean room alert limits with a new standard. |
| P080006/S041 7/11/12 |
Attain Ability Lead | Medtronic, Inc. Mounds View, MN 55112 |
Update the drug component and finished lead specification of the Attain Ability family of leads and the addition of an alternate testing laboratory an alternate analytical methods. |
| P080011/S013 7/3/12 |
CooperVision Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision, Incorporated Pleasanton, CA 94588 |
Installation of two (upgraded injection molding and change in the design of the peel module) additional manufacturing lines. |
| P080011/S014 7/9/12 |
CooperVision Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision, Incorporated Pleasanton, CA 94588 |
Update of software for all lines excluding line 11. |
| P080011/S016 7/17/12 |
Biofinity (comfilcon A) Soft (Hydrophilic) Extended-Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Requalification of manufacturing equipment. |
| P080014/S013 7/3/12 |
Cervista® Human Papilloma Virus (HPV) High Risk (HR) | Hologic LP Marlborough, MA 01752 |
Change in the Clinical Development Database software from Version 5.9 to Version 6.0. |
| P080015/S008 7/6/12 |
Cervista™ HPV 16/18 | Hologic, LP Marlborough, MA 01752 |
Change in the Clinical Development Database software from Version 5.9 to Version 6.0. |
| P090013/S064 7/5/12 |
CapSureFix MRI Lead | Medtronic CDRM Mounds View, MN 55112 |
Additional supplier for the vein lifter component. |
| P090013/S065 7/26/12 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Addition of an in-process inspection of the hybrid cathode mix ratio. |
| P100013/S004 7/20/12 |
EXOSEAL Vascular Closure Device | Cordis Corporation Bridgewater, NJ 08807 |
Several manufacturing changes to supplier provided molded components. |
| P100021/S019 7/11/12 |
Endurant Stent Grafts | Medtronic Vascular Santa Rosa, CA 95403 |
Removal of a surfactant from one of the steps in graft manufacturing at the contract supplier. |
| P100023/S044 7/6/12 |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of new software to interface with the Manufacturing Execution System (MES). |
| P100023/S045 7/11/12 |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Perform manual measurement of the proximal balloon bond. |
| P100023/S046 7/11/12 |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the location of a critical component supplier. |
| P100023/S048 7/26/12 |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software modification to the balloon stretching process. |
| P100024/S002 7/31/12 |
HER2 CISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Manufacturing process of PNA oligomers in the device. |
| P100041/S012 7/11/12 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences LLC Irvine, CA 92614 |
An increase in the number of HEPA filters in a gowning room and the addition of corresponding hand dryers, and remodeling of a transfer room to include an emergency exit corridor and emergency exit door. |
| P110001/S006 7/11/12 |
RX Herculink Elite Renal and Biliary Stent System | Abbott Vascular Temecula, CA 92590 |
Align clean room alert limits with a new standard. |
| P110001/S007 7/11/12 |
RX Herculink Elite Renal Stent System | Abbott Vascular Temecula, CA 92589 |
Change to sample size for pyrogen testing. |
| P110010/S015 7/6/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of new software to interface with the Manufacturing Execution System (MES). |
| P110010/S016 7/11/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Perform manual measurement of the proximal balloon bond. |
| P110010/S017 7/11/12 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the location of a critical component supplier. |
| P110010/S019 7/20/12 |
PROMUS Element Plus Everolimus-Eluting Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software and hardware changes to the ethylene oxide sterilization Chamber 1. |
| P110010/S022 7/26/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software modification to the balloon stretching process. |
| P110010/S023 7/27/12 |
PROMUS Element Plus Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of the listed devices to the approved list of PMAs processed by a contract sterilizer. |
| P110013/S004 7/25/12 |
Resolute Integrity Zotarolimus Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Removal of a finished device inspection step. |
| P110019/S024 7/11/12 |
XIENCE PRIME Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92590 |
Align clean room alert limits with a new standard. |
| P110023/S003 7/6/12 |
EverFlex Self-Expanding Peripheral Stent System | eV3 Plymouth, MN 55441 |
Utilize an upsized final expansion mandrel. |
| P110028/S004 7/11/12 |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular Temecula, CA 92589 |
Change to sample size for pyrogen testing. |
| P110029/S002 7/3/12 |
ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Change to the quality control method used for anti-HBs testing for incoming human plasma units. |
| P110035/002 7/11/12 |
Epic Vascular Self-Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Critical component supplier site change. |
