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PMA Final Decisions for January 2013

Wed, 03/20/2013 - 12:00am
U.S. Food & Drug Administration

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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE 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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