News

PMA Final Decisions for January 2013

Wed, 03/20/2013 - 12:00am

U.S. Food & Drug Administration

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Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

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
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.

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

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PMA Original Approvals

PMA Supplemental Approvals

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

Topics

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FREE

Email Newsletter

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Compact One-Piece Antenna Contact Technology

Laboratory Testing Inc. Offers New Radiography Capabilities

Medical-Grade TPEs Provide Real-World Alternative

Ultra-small 7S Series of 7mm Incremental Rotary Encoders

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