Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 48
Summary of PMA Originals Under Review
Total Under Review: 50
Total Active: 21
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 498
Total Active: 358
Total On Hold: 140
Summary of All PMA Submissions Received
Originals: 2
Supplements: 43
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 48
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 145.5
FDA Time: 111.9 Days MFR Time: 33.6 Days
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P120016 1/31/13 |
VASCADE™ Vascular Closure System (VCS) | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Approval for the VASCADE™ Vascular Closure System (VCS). This device is indicated for femoral arterial access site closure while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5F, 6F, or 7F procedural sheath. The Vascade VCS is also indicated to reduce time to discharge eligibility in patients who have undergone diagnostic endovascular procedures using a 5F, 6F, or 7F procedural sheath. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N18286/S024 1/7/13 Real-Time |
Absorbable Hemostatic Agent; Gelfoam® (absorbable gelatin) Powder, USP | Pfizer, Incorporated New York, NY 10017 |
Approval for a minor change in labeling instructions to include mixing Gelfoam Powder with diluents of saline for injection or Thrombin. The device along with the modified labeling will be marketed under the trade name Gelfoam absorbable gelatin powder: Is intended as a hemostatic device for surgical procedures when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is either ineffective or impractical. Although not necessary, GELFOAM Sterile Powder can be used either with or without Thrombin to obtain hemostasis. |
| P790007/S032 1/10/13 180-Day |
Hancock Modified Orifice Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for the glutaraldehyde stock solution that is obtained from Dow Chemical for the fixative, storage, and sterilization solutions to be changed from a 25% stock solution to a 50% stock solution. |
| P810031/S046 1/11/13 Real-Time |
Sodium Hyaluronate Opthalmic Viscoelastic Devices (OVD), Healon®, Healon GV®, Healon5® products | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for a new secondary carton package containing one Heaton OVD (0.55 ml) and one Heaton® EndoCoat OVD (0.85 ml). The device, as modified, will be marketed under the trade name Heaton Duet Dual Pack and is indicated for: Healon: Heaton® OVD is intended for use as a surgical aid in cataract extraction (intra- and extracapsular), IOL implantation, corneal transplant, glaucoma filtration and retinal attachment surgery. Heaton Endocoat: Heaton® EndoCoat OVD, model VT585 is intended for use as a surgical aid in patients undergoing ophthalmic anterior segment procedures including: 1) Cataract surgery with an intraocular lens; 2) Cataract surgery without an intraocular lens; and 3) Secondary intraocular lens implantation. Heaton® EndoCoat OVD maintains a deep chamber during anterior segment surgery, aids in tissue manipulation during 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. |
| P860004/S175 1/7/13 Real-Time |
Ascenda Intrathecal Catheters | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for a minor design control change, and subsequent manufacturing process changes, to remove the lack of lamination note from the pump and spinal catheter segments assembly level prints for the device. |
| P870078/S015 1/10/13 180-Day |
Hancock Low Porosity Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for the glutaraldehyde stock solution that is obtained from Dow Chemical for the fixative, storage, and sterilization solutions to be changed from a 25% stock solution to a 50% stock solution. |
| P890003/S252 1/15/13 180-Day |
CareLink Monitor CardioSight Reader and Device Data Management Application (DDMA) |
Medtronic, Inc. Mounds View, MN 55112 |
Approval of an MR-conditional system permitting implanted patients to undergo MRI scans provided specified conditions are met. The devices, as modified, make up the Advisa DR MRI SureScan system and will be marketed under the trade names Advisa DR MRI A2DR01 Implantable Pulse Generator with Software Model 9995, CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and DDMA Model 2491. The Advisa DR MRI SureScan system is indicated for the following: 1) Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity; and 2) Accepted patient conditions warranting chronic cardiac pacing include: a) Symptomatic paroxysmal or permanent second-or third-degree A V block; b) Symptomatic bilateral bundle branch block; c) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated A V conduction disorders d) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and e) Vasovagal syndromes or hypersensitive carotid sinus syndromes The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include: 1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and 2) VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm Antitachycardia pacing (A TP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications. |
| P890003/S253 1/29/13 180-Day |
CareLink Home Monitor, CardioSight® Reader, CareLink Express™ Monitor and CareLink Network Device Data Management Application |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Viva/Brava Implantable Cardioverter Defibrillators with Cardiac Resynchronization (CRT-D). |
| P890055/S047 1/16/13 Real-Time |
Codman 3000 Series Constant Flow Implantable Infusion Pump; MedStream Programmable Infusion Pump | Codman & Shurtleff, Incorporated Raynham, MA 02767 |
Approval for a change to the epidural filter component of the MedStream Refill and Bolus Kit, Operating Room (O.R.) Prep Kit, and Instraspinal Catheter Kit. |
| P910077/S119 1/28/13 180-Day |
LATITUDE Wave Communicator and System Software LATITUDE NXT Software for the LATITUDE Patient Management System | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the LATITUDE Wave Communicator, Model 6498 and System Software LATITUDE NXT, Model 6460 Software, Version 1.01.04 for the LATITUDE Patient Management System. |
| P950037/S117 1/31/13 Real-Time |
Dromos DR/SR Rate Adaptive Pacing System | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Updates to the Home Monitoring Service Center with 5 software versions, v3.8.1, v3.9.0, v3.10.0, v3.11.0, v3.12.0; and the CardioMessenger II9-LLT) |
| P970031/S036 1/10/13 180-Day |
Freestyle Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for the glutaraldehyde stock solution that is obtained from Dow Chemical for the fixative, storage, and sterilization solutions to be changed from a 25% stock solution to a 50% stock solution. |
| P970051/S093 1/3/13 Real-Time |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Approval for a new version of the Custom Sound software for programming of the Nucleus cochlear implants, to be known as Custom Sound 3.3. |
| P980016/S363 1/3/13 180-Day |
ENTRUST, INTRINSIC, MARQUIS, MAXIMO, PROTECTA, SECURA AND VIRTUOSO ICD FAMILIES | Medtronic, Inc. Mounds View, MN 55112 |
Approval to update the device labeling with the results from the Right Ventricular Lead Integrity Alert (RV LIA) post-approval stud (PAS). |
| P980022/S125 1/29/13 Real-Time |
Paradigm REAL-Time System and Paradigm REAL-Time Revel System | Medtronic, Inc. Northridge, CA 91325 |
Approval for design changes to the drive support cap, case bottom bore and additional glue for the Paradigm REAL-Time Insulin Pumps (MMT-722, MMT-722K) and Paradigm REAL-Time Revel Insulin Pump (MMT-723, MMT-723K), as components of the Paradigm REAL-Time and Paradigm REAL-Time Revel System. |
| P980023/S050 1/31/13 Real-Time |
Phylax ICD System | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Updates to the Home Monitoring Service Center with 5 software versions, v3.8.1, v3.9.0, v3.10.0, v3.11.0, v3.12.0; and the CardioMessenger II9-LLT) |
| P980035/S277 1/15/13 180-Day |
Advisa DR MRI A2DR01 Implantable Pulse Generator, Software | Medtronic, Inc. Mounds View, MN 55112 |
Approval of an MR-conditional system permitting implanted patients to undergo MRI scans provided specified conditions are met. The devices, as modified, make up the Advisa DR MRI SureScan system and will be marketed under the trade names Advisa DR MRI A2DR01 Implantable Pulse Generator with Software Model 9995, CareLink Monitor Model 2490G, CardioSight Reader Model 2020A and DDMA Model 2491. The Advisa DR MRI SureScan system is indicated for the following: 1) Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in activity; and 2) Accepted patient conditions warranting chronic cardiac pacing include: a) Symptomatic paroxysmal or permanent second-or third-degree A V block; b) Symptomatic bilateral bundle branch block; c) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated A V conduction disorders d) Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and e) Vasovagal syndromes or hypersensitive carotid sinus syndromes The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include: 1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and 2) VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm Antitachycardia pacing (A TP) is indicated for termination of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications. |
| P980037/S039 1/9/13 180-Day |
AngioJet® Rheolytic™ Thrombectomy System, AngioJet Ultra Distaflex Thrombectomy Set |
MEDRAD, Inc. Minneapolis, MN 55433 |
Approval for a new device, the AngioJet Ultra System with the Distaflex Thrombectomy Set with a 3 French distal diameter. The device, as modified, will be marketed under the trade name AngioJet Ultra System with the Distaflex Thrombectomy Set and is indicated for removing thrombus in the treatment of patients with symptomatic coronary artery or SVG lesions in vessels ≥ 2.0 mm in diameter prior to balloon angioplasty or stent placement. |
| P980043/S034 1/10/13 180-Day |
Hancock II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for the glutaraldehyde stock solution that is obtained from Dow Chemical for the fixative, storage, and sterilization solutions to be changed from a 25% stock solution to a 50% stock solution. |
| P990004/S023 1/9/13 135-Day |
SURGIFOAM Absorbable Gelatin Sponge | ETHICON, Inc. Somerville, NJ 08876 |
Approval for a change in the location of the Ferrosan Medical Devices A/S (FeMD) testing laboratory in Soeborg, Denmark. |
| P990027/S017 1/18/13 180-Day |
TECHNO LAS 217 A Excimer Laser System LAS 217z Zyoptix System for Personalized Vision Correction for wavefront guided laser assisted in-situ keratomileusis (LASIK) treatments for the reduction or elimination of myopia with sphere up to -7.00D and cylinder up to -3.00D and MRSE ≤ 7.50D at the spectacle plane | Technolas Perfect Vision GmbH San Francisco, CA 94114 |
Approval for an alternate source to produce the Thyratron Power Supply and Laser Head assemblies. |
| P990064/S041 1/10/13 180-Day |
Mosaic Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Approval for the glutaraldehyde stock solution that is obtained from Dow Chemical for the fixative, storage, and sterilization solutions to be changed from a 25% stock solution to a 50% stock solution. |
| P000006/S029 1/29/13 Real-Time |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Approval for the following modifications to the Titan Narrow Base Cylinder (11 and 14 cm lengths only): (i) change of the angle of the tubing from 22.5° to 0°, and (ii) change in cylinder tip material from dipped-on Bioflex to bonded-on MED 4750. |
| P000009/S052 1/31/13 Real-Time |
Phylax AV ICD System | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Updates to the Home Monitoring Service Center with 5 software versions, v3.8.1, v3.9.0, v3.10.0, v3.11.0, v3.12.0; and the CardioMessenger II9-LLT) |
| P000040/S026 1/11/13 Real-Time |
Genesys HTA™ System | Boston Scientific Corporation Marlborough, MA 01752 |
Approval to replace obsolete components in the control unit and make changes to other components to accommodate these new parts. |
| P010012/S301 1/18/13 180-Day |
Cardiac Resynchronization Therapy Defibrillator (CRT-D) |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval of the post-approval study protocol. |
| P010014/S039 1/4/13 180-Day |
Oxford™ Meniscal Unicompartmental Knee System | Biomet Warsaw, IN 46581 |
Approval of the post-approval study protocol. |
| P010031/S315 1/3/13 180-Day |
CONCERTO, CONSULTA, INSYNC MAXIMO, PROTECTA ICD AND CRT-D FAMILIES | Medtronic, Inc. Mounds View, MN 55112 |
Approval to update the device labeling with the results from the Right Ventricular Lead Integrity Alert (RV LIA) post-approval study (PAS). |
| P010031/S318 1/29/13 180-Day |
Viva/ Brava CRT-D devices and Brava™ CRT-D Implantable Cardioverter Defibrillators with Cardiac Resynchronization | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Viva/Brava Implantable Cardioverter Defibrillators with Cardiac Resynchronization (CRT-D). |
| P010032/S059 1/9/13 135-Day |
Eon Mini Neurostimulation System | St. Jude Medical Plano, TX 75024 |
Approval for the revision to the manufacturing process for Eon Mini (Model 3788) implantable pulse generator headers. |
| P040008/S003 1/18/13 Real-Time |
VIDAS® Total PSA | bioMerieux, Inc. Hazelwood, MO 63042 |
Approval for updating the packaging insert by defining the phrase "instrument of the VIDAS family" as "Instrument of the VIDAS family: VIDAS or miniVIDAS" and replacing "instruments of the VIDAS family" with "VIDAS instruments" in the intended use. The device, VIDAS® Total PSA, is intended for use with the VIDAS instruments (VITEK® lmmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantitative measurement of total prostate specific antigen in human serum. The VIDAS TPSA assay is indicated as an aid in the management of patients with prostate cancer and as an aid in the detection of prostate cancer in conjunction with digital rectal examination (ORE) in men age 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer. The device, VIDAS® Free PSA rt, is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of the free fraction of prostate specific antigen (PSA) in human serum using the ELF A technique (Enzyme Linked Fluorescent Assay). The VIDAS Free PSA rt is intended to be used in conjunction with the VIDAS TPSA assay in men age 50 years or older who have digital rectal examination (ORE) that is not suspicious for prostate cancer and VIDAS TPSA values between 4 and 10 ng/mL to determine the % Free PSA value. The VIDAS % Free PSA value can be used as an aid in discriminating between prostate cancer and benign disease. Prostate biopsy is required for diagnosis of prostate cancer. |
| P040044/S044 1/9/13 Real-Time |
Mynx Cadence® and MynxGrip™ Vascular Closure Device | AccessClosure, Inc. Mountain View, CA 94043 |
Approval for minor packaging modifications to the packaging tray. |
| P050018/S017 1/10/13 180-Day |
AngioSculpt® PTCA Scoring Balloon Catheter | AngioScore, Inc. Fremont, CA 94538 |
Approval for a new balloon length, and to incorporate design, manufacturing process and labeling changes for the Rapid Exchange (RX) delivery system. |
| P050023/S056 1/11/13 180-Day |
Corox OTW Steroid LV Pacing Lead | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for updating the labeling for the Corox Family Over The Wire (OTW) Left Ventricular (LV) Pacing Lead to reflect the findings of the Corox OTW Steroid LV Monitoring (COSMO) Post-Approval Study. |
| P050023/S059 1/31/13 Real-Time |
Tupos LV/ATx and Kronos LV-T CRT-D System | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Updates to the Home Monitoring Service Center with 5 software versions, v3.8.1, v3.9.0, v3.10.0, v3.11.0, v3.12.0; and the CardioMessenger II9-LLT) |
| P050028/S028 1/2/13 Real-Time |
COBAS® AmpliPrep/COBAS® TaqMan® HBV Test, v2.0, COBAS® TaqMan® HBV Test For Use With The High Pure System | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a new version of AMPLILINK software, v3.3.7. |
| P050050/S005 1/24/13 Special |
Scandinavian Total Ankle Replacement System (STAR Ankle) | Small Bone Innovations, Incorporated Morrisville, PA 19067 |
Approval for a revised package insert which includes additional potential adverse events reported in recent STAR Ankle publications. |
| P060002/S027 1/16/2013 180-Day |
FLAIR® Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for a line extension of the FLAIR® Endovascular Stent Graft to add a 70 mm length. In addition, there are three additional minor changes. These included: Manufacturing Core Modification, Delivery System Flaring Mandrel Modification, and Chamfer of Guiding Tube Modification. |
| P060030/S030 1/2/13 Real-Time |
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, COBAS® TaqMan® HCV Test v2.0 For Use With The High Pure System |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a new version of AMPLILINK software, v3.3.7. |
| P070008/S037 1/31/13 Real-Time |
Stratos LV/LV-T Cardiac Resynchronization Therapy Pacemaker (CRT-P) Systems |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Updates to the Home Monitoring Service Center with 5 software versions, v3.8.1, v3.9.0, v3.10.0, v3.11.0, v3.12.0; and the CardioMessenger II9-LLT) |
| P080008/S002 1/18/13 Real-Time |
VIDAS® Free PSA rt |
bioMerieux, Inc. Hazelwood, MO 63042 |
Approval for updating the packaging insert by defining the phrase "instrument of the VIDAS family" as "Instrument of the VIDAS family: VIDAS or miniVIDAS" and replacing "instruments of the VIDAS family" with "VIDAS instruments" in the intended use. The device, VIDAS® Total PSA, is intended for use with the VIDAS instruments (VITEK® ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELFA) for the quantitative measurement of total prostate specific antigen in human serum. The VIDAS TPSA assay is indicated as an aid in the management of patients with prostate cancer and as an aid in the detection of prostate cancer in conjunction with digital rectal examination (ORE) in men age 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer. The device, VIDAS® Free PSA rt, is an automated quantitative test for use on the VIDAS instruments, for the quantitative measurement of the free fraction of prostate specific antigen (PSA) in human serum using the ELF A technique (Enzyme Linked Fluorescent Assay). The VIDAS Free PSA rt is intended to be used in conjunction with the VIDAS TPSA assay in men age 50 years or older who have digital rectal examination (ORE) that is not suspicious for prostate cancer and VIDAS TPSA values between 4 and 10 ng/mL to determine the % Free PSA value. The VIDAS % Free PSA value can be used as an aid in discriminating between prostate cancer and benign disease. Prostate biopsy is required for diagnosis of prostate cancer. |
| P090022/S012 1/29/13 180-Day |
Softec HD Posterior Chamber Intraocular Lens (IOL) Preloaded Injector (PLI) IOL Delivery System | Lenstec, Inc. St. Petersburg, FL 33716 |
Approval for the Preloaded Injector (PLI) Intraocular Lens (IOL) Delivery System. |
| P100018/S005 1/18/13 Special |
Pipeline™ Embolization Device | ev3 Neurovascular Irvine, CA 92618 |
Approval for revisions and additional warnings to the Instructions for Use. |
| P100023/S047 1/29/13 135-Day |
ION Paclitaxel Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for an update to the distal weld inspection criteria for acceptable bubble size. |
| P100049/S003 1/24/13 180-Day |
LINX® Reflux Management System | Torax Medical, Inc. Shoreview, MN 55126 |
Approval for a design change that incorporates a clasp into the LINX device. |
| P110010/S018 1/29/13 135-Day |
PROMUS Element Plus Everolimus Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for an update to the distal weld inspection criteria for acceptable bubble size. |
| P110020/S006 1/10/13 180-Day |
cobas® 4800 BRAF V600 Mutation Test | Roche Molecular Systems Pleasanton, CA 94588 |
Approval for the addition of poly rA to the BRAF Mutant and Wild-type Controls buffer matrix and associated manufacturing process changes. |
| P110029/S001 1/10/13 180-Day |
ARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Approval for the migration of the ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory assays to the ARCHITECT i lOOOSR analyzer. |
| P110037/S003 1/7/13 Real-Time |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for two new versions of AMPLILINK software, v3.3.6 and v3.3.7. |
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/S034 1/8/13 |
Hancock Modified Orifice Valved Conduit | Medtronic Heart Valves Santa Ana, CA 92705 |
Expansion of a cleanroom. |
| P830061/S084 1/3/13 |
CapSure Lead, CapSure Sense Bipolar Lead, Vitatron Crystaline Lead, Vitatron Excellence PS+ Lead | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P840001/S231 1/8/13 |
SNS Family of Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use an updated version of the software already in use at various facilities to ensure compliance to training requirements, proper documentation associated with disposition of product, and proper function of the software by correcting minor issues present in the current software version. |
| P850079/S064 1/17/13 |
Methafilcon A and Methafilcon B Soft (Hydrophilic) Extended-Wear Contact Lenses | CooperVision, Incorporated Pleasanton, CA 94588 |
Relocate and revalidate manufacturing equipment. |
| P850089/S092 1/3/13 |
CapSure SP Novus, CapSure Z Novus, Impulse II Leads | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P860004/S181 1/8/13 |
Medtronic SynchroMed Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use an updated version of the software already in use at various facilities to ensure compliance to training requirements, proper documentation associated with disposition of product, and proper function of the software by correcting minor issues present in the current software version. |
| P860004/S182 1/8/13 |
SynchroMed II Implantable Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
In-process inspection step be implemented. |
| P860047/S027 1/29/13 |
OcuCoat Ophthalmic Viscosurgical Device | Bausch & Lomb Aliso Viejo, CA 92656 |
Addition of an alternate diluent for endotoxin testing. |
| P860057/S101 1/8/13 |
Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis; Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount RSR Pericardial Aortic Bioprosthesis; Carpentier-Edwards Perimount Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Pericardial Aortic Bioprosthesis; Carpentier- Edwards Perimount Magna Pericardial Aortic Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Plus Pericardial Mitral Bioprosthesis; Carpentier-Edwards Perimount Theon Pericardial Mitral Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis; Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis; Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process; Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis; and Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprosthesis with ThermaFix tissue process |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Software modification to the automated mixing, storage and delivery system used in the manufacture of several models of the Carpentier-Edwards Perimount Aortic and Mitral Valve Bioprostheses. |
| P860057/S102 1/30/13 |
Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of two liter jar torque machine. |
| P870078/S018 1/8/13 |
Hancock Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Expansion of a cleanroom. |
| P880081/S038 1/29/13 |
Phaco-Flex and the TECHIS CL | Abbott Medical Optics, Inc. Santa Ana, CA 92705 |
Eliminate cytotoxicity testing conducted on finished intraocular lenses. |
| P890003/S267 1/3/13 |
CapSure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P900056/S119 1/24/13 |
Rotablator Rotational Atherectomy System | Boston Scientific Corporation Maple Grove, MN 55311 |
Automation of an environmental monitoring system at the Heredia, Costa Rica facility. |
| P910001/S063 1/8/13 |
Spectranetics CVX-300 Excimer Laser System | Spectranetics Corporation Colorado Springs, CO 80921 |
Alternate supplier for cable assemblies. |
| P920015/S102 1/3/13 |
“Y” Adaptor/ Extender Kit, Sprint Quattro Lead | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P920015/S103 1/15/13 |
Sprint Quattro Leads | Medtronic, Inc. Mounds View, MN 55112 |
Relocation and refurbishment of an injection molding press. |
| P920015/S104 1/17/13 |
Sprit Quattro Secure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of a label laser marking process and addition of a 2D matrix to the label. |
| P920047/S054 1/22/13 |
Blazer II Cardiac Ablation Catheters | Boston Scientific Corporation St. Paul, MN 55112 |
Transfer of the endotoxin (LAL) testing to a new location. |
| P930014/S065 1/17/13 |
AcrySof Posterior Chamber Intraocular Lenses | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
New curing oven. |
| P930039/S080 1/3/13 |
SureFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P930039/S081 1/15/13 |
Vitatron Crystalline Lead | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of laser welding equipment. |
| P960009/S161 1/8/13 |
DBS Family of Devices | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use an updated version of the software already in use at various facilities to ensure compliance to training requirements, proper documentation associated with disposition of product, and proper function of the software by correcting minor issues present in the current software version. |
| P960040/S283 1/10/13 |
Incepta, Energen, Punctua and Telegen ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of an inspection at the supplier and updates to the crystal component drawing. |
| P960040/S284 1/22/13 |
Teligen, Incepta, Energen and Punctua ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Changes to the sputtered ceramic lapping process used during feedthru assembly. |
| D970003/S147 1/10/13 |
Advantio and Ingenio Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of an inspection at the supplier and updates to the crystal component drawing. |
| D970003/S149 1/17/13 |
Ingenio Pacemakers and Advantio Pacemakers | Boston Scientific Corporation St. Paul, MN 55112 |
New settings for manufacturing equipment. |
| P970004/S147 1/8/13 |
SNS Urinary Family of Devices | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use an updated version of the software already in use at various facilities to ensure compliance to training requirements, proper documentation associated with disposition of product, and proper function of the software by correcting minor issues present in the current software version. |
| P970031/S038 1/8/13 |
Freestyle Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Expansion of a cleanroom. |
| P980016/S393 1/3/13 |
Maximo II, Protecta, Protecta XT, Secura, Virtuoso II DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P980043/S038 1/8/13 |
Hancock II Bioprosthetic Heart Valve | Medtronic Heart Valves Santa Ana, CA 92705 |
Expansion of a cleanroom. |
| P980049/S078 1/16/13 |
Paradym VR and DR, Paradym RF VR and DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Change to the gluing equipment. |
| P990064/S046 1/8/13 |
Mosaic Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Expansion of a cleanroom. |
| P000037/S032 1/8/13 |
On-X Prosthetic Heart Valve | On-X Technologies, Inc. Austin, TX 78752 |
Change the suspension agent-to-water mixing ratio of polishing slurry of the vibratory polish process. |
| P010012/S317 1/10/13 |
Incepta, Energen, Punctua and Cognis CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of an inspection at the supplier and updates to the crystal component drawing. |
| P010012/S318 1/22/13 |
Cognis, Incepta, Energen and Punctua CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Changes to the sputtered ceramic lapping process used during feedthru assembly. |
| P010015/S186 1/3/13 |
Attain Bipolar OTW Lead | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P010031/S343 1/3/13 |
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II, Protecta XT, Protecta CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P010032/S065 1/16/13 |
Eon Mini Neurostimulation System | St. Jude Medical Plano, TX 75024 |
Method of remanufacturing of the charger. |
| P020011/S006 1/9/13 |
APTIMA® HCV RNA Qualitative Assay | Gen-Probe Incorporated San Diego, CA 92121 |
Modification to the quality control release testing for the reagents kits. |
| P020025/S037 1/22/13 |
Blazer Prime Cardiac Ablation Catheters | Boston Scientific Corporation St. Paul, MN 55112 |
Transfer of the endotoxin (LAL) testing to a new location. |
| P030005/S094 1/10/13 |
Invive CRT-P | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of an inspection at the supplier and updates to the crystal component drawing. |
| P030005/S096 1/15/13 |
Invive CRT-P | Boston Scientific Corporation St. Paul, MN 55112 |
New settings for manufacturing equipment. |
| P030009/S062 1/15/13 |
Integrity RX & OTW Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Addition of a leak tester and the removal of an Acceptable Quality Limit test requirement. |
| P030017/S147 1/3/13 |
Precision Spinal Cord Stimulator System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Change to the metal casting frame cleaning process. |
| P030017/S151 1/16/13 |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Corporation Valencia, CA 91355 |
Alternate grinder with automatic features for the spinal cord stimulator. |
| P040008/S004 1/15/13 |
VIDAS Total PSA | bioMérieux, Inc. Hazelwood, MO 63042 |
Add a new qualified supplier for an incoming raw material. |
| P040012/S051 1/24/13 |
Acculink Carotid Stent System | Abbott Vascular Temecula, CA 92591 |
Manufacturing transfer for the delivery systems of the devices within the same site. |
| P040020/S044 1/17/13 |
AcrySof ReSTOR Posterior Chamber Intraocular Lenses | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
New curing oven. |
| P040037/S044 1/4/13 |
Gore VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Alternate resin raw material for the devices. |
| P040037/S045 1/15/13 |
Gore VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Change in RF bonding parameters. |
| P040038/S028 1/24/13 |
XACT Carotid Stent System | Abbott Vascular Temecula, CA 92591 |
Manufacturing transfer for the delivery systems of the devices within the same site. |
| P040044/S046 1/24/13 |
Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 |
Addition of a two-shelf freeze dryer. |
| P040045/S035 1/17/13 |
VISTAKON (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Alternate new test method for the contact angle of VISTAKON (senofilcon A) Brand Contact Lenses. |
| P050034/S008 1/22/13 |
Implantable Miniature Telescope | VisionCare Ophthalmic Technologies Saratoga, CA 95070 |
Minor changes to the routine sterilization process. |
| P050038/S012 1/9/13 |
ARISTA AH Absorbable Hemostat | Medafor, Inc. Minneapolis, MN 55430 |
Change in short term storage conditions in the powder filler for relative humidity controls and the addition of 100% weight inspection post filling. |
| P050038/S013 1/10/13 |
ARISTA AH Absorbable Hemostat | Medafor, Inc. Minneapolis, MN 55430 |
Qualification of additional manufacturing equipment. |
| P060023/S004 1/11/13 |
Bryan Cervical Disc | Medtronic Sofamor Danek USA, Inc. Memphis, TN 38132 |
Use of a new location for the porous coating process performed at the firm’s supplier. |
| P060027/S046 1/16/13 |
Paradym CRT-D, Paradym RF CRT-D | Sorin CRM USA, Inc. Arvada, CO 80004 |
Change to the gluing equipment. |
| P060039/S041 1/3/13 |
Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P080006/S049 1/3/13 |
Attain Ability Lead | Medtronic, Inc. Mounds View, MN 55112 |
Alternate suppliers for multiple silicone components. |
| P080011/S020 1/9/13 |
Biofinity (comfilcon A) Soft Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Change to use a new mold material for the manufacture of comfilcon A extended-wear contact lenses. |
| P080011/S021 1/17/13 |
Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Relocate and revalidate manufacturing equipment. |
| P080011/S022 1/17/13 |
Biofinity (comfilcon A) Soft Extended-Wear Contact Lenses | CooperVision, Inc. Pleasanton, CA 94588 |
Change in the supply chain for the raw material, used in the manufacture of comfilcon A extended-wear contact lenses. |
| P080012/S010 1/22/13 |
Prometra Programmable Infusion Pump System | Flowonix Medical, Inc. Mount Olive, NJ 07828 |
Addition of an alternate sub-tier supplier of a component of the device. |
| P080025/S043 1/8/13 |
SNS Bowel Family of Devices | Medtronic Neuromodulation Minneapolis, MN 55432 |
Use an updated version of the software already in use at various facilities to ensure compliance to training requirements, proper documentation associated with disposition of product, and proper function of the software by correcting minor issues present in the current software version. |
| P080027/S008 1/24/13 |
OraQuick® HCV Rapid Antibody Test | OraSure Technologies, Inc. Bethlehem, PA 18015 |
Change in the preservative used in the manufacture of the device. |
| P100023/S067 1/8/13 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Two software updates to the midshaft hot jaw bonding process. |
| P100041/S020 1/30/13 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of two liter jar torque machine. |
| P100044/S005 1/17/13 |
Propel Mini Sinus Implant | Intersect ENT Menlo Park, CA 94025 |
Change to the packaging process. |
| P100047/S004 1/4/13 |
HeartWare Left Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Use of an additional Ethylene Oxide sterilization chamber at Sterigenics, located in Salt Lake City, Utah. |
| P100047/S008 1/7/13 |
HeartWare® Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Implementation of a modified polishing/ buffing process for the coated impellers, which are used with the device. |
| P100047/S011 1/3/13 |
HeartWare Left Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Relocation of operations of a critical supplier. |
| P100047/S012 1/2/13 |
HeartWare Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Change in software algorithm to calculate in-process values. |
| P110001/S010 1/24/13 |
RX Herculink Elite Renal Stent System | Abbott Vascular Temecula, CA 92591 |
Manufacturing transfer for the delivery systems of the devices within the same site. |
| P110010/S043 1/8/13 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) | Boston Scientific Corporation Maple Grove, MN 55311 |
Two software updates to the midshaft hot jaw bonding process. |
| P110010/S044 1/30/13 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Reduction in sample size using analytical chemistry methods for identifying Everolimus and for determining degradation and impurities. |
| P110021/S006 1/30/13 |
Edwards SAPIEN Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of two liter jar torque machine. |
| P110028/S006 1/24/13 |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular Temecula, CA 92591 |
Manufacturing transfer for the delivery systems of the devices within the same site. |
| P120005/S001 1/4/13 |
Dexcom G4 Platinum Continuous Glucose Monitoring System | Dexcom San Diego, CA 92121 |
Semi-automate the sub-assembly Disposable Seal (DS) process used in the G4 Continuous Glucose Monitoring System. Additionally, a new clean room was added to accommodate the new Disposable Seal Machine and provide additional manufacturing capacity for the other processes. |
