Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 79
Summary of PMA Originals Under Review
Total Under Review: 47
Total Active: 20
Total On Hold: 27
Summary of PMA Supplements Under Review
Total Under Review: 372
Total Active: 252
Total On Hold: 120
Summary of All PMA Submissions Received
Originals: 2
Supplements: 80
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 79
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 211.6
FDA Time: 122 Days MFR Time: 89.6 Days
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P040046 2/20/13 |
Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410FM, 410FF, 410MM and 410MF) |
Allergan Goleta, CA 93117 |
Approval for the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants. This device is indicated for women for the following uses (procedures): 1) Breast Augmentation for women at least 22 years old. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery; and 2) Breast Reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. |
P110032 2/14/13 |
Aorfix AAA Flexible Stent Graft System | Lombard Medical Westwood, MA 02090 |
Approval for the Aorfix AAA Flexible Stent Graft System. This device is indicated for the treatment of patients with abdominal aortic and aorto-iliac aneurysms having vascular morphology suitable for endovascular repair, including: 1) Adequate iliac or femoral access that is compatible with vascular access techniques, implants, and accessories; 2) Aortic neck landing zone diameters with a range of 19mm to 29mm; 3) Non aneurysmal proximal neck center-line length of ≥ l5mm; 4) lnfrarenal aortic neck angulations including those up to and including 90° 5) Common iliac landing zone diameters with a range of 9mm to 19mm; and 6) Distal fixation length of ≥ 15mm. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
N16837/S010 2/25/13 135-Day |
Artegraft Collagen Vascular Graft | Artegraft Incorporated North Brunswick, NJ 08902 |
Approval for the addition of Maverick Biosciences Pty Ltd as an alternate supplier or source of the bovine carotid artery in Artegraft Collagen Vascular Graft. |
P790002/S028 2/8/13 180-Day |
Biomet® EBI Bone Healing System | EBI, L.L.C. Parsippany, NJ 07054 |
Approval for a modified, redesigned, electronic controller with a non-replaceable lithium-ion battery and a new extremity band accessory. |
P810002/S080 2/19/13 180-Day |
SJM Masters HP Valved Graft with Gelweave Valsalva Technology | St. Jude Medical Inc. St. Paul, MN 55117 |
Approval for a manufacturing site located at St. Jude Medical Arecibo, in Arecibo, Puerto Rico. |
P830061/S073 2/28/13 180-Day |
CapSure, Vitatron Crystaline, and Vitatron Excellence PS+ pacemaker leads | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the CapSure, Vitatron Crystaline, and Vitatron Excellence PS+ pacemaker leads. |
P850089/S085 2/28/13 180-Day |
CapSure, CapSure Z Novus, and Vitatron Impulse II pacemaker leads | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the CapSure, CapSure Z Novus, and Vitatron Impulse II pacemaker leads . |
P860003/S069 2/15/13 Special |
THERAKOS UVAR™ XTS® and CELLEX® Photopheresis Systems | THERAKOS, Inc. Raritan, NJ 08869 |
Approval for labeling modifications to include a warning statement regarding the use of the device on the same day as other procedures that may cause significant fluid changes in a patient. |
P860057/S098 2/28/13 135-Day |
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 |
Edward Lifesciences, LLC Irvine, CA 92614 |
Approval to use an alternate process manufacturing aid to dispense glutaraldehyde. |
P870056/S055 2/28/13 135-Day |
Carpentier-Edwards Porcine Aortic Bioprosthesis, Carpentier-Edwards Porcine Mitral Bioprosthesis |
Edward Lifesciences, LLC Irvine, CA 92614 |
Approval to use an alternate process manufacturing aid to dispense glutaraldehyde. |
P870077/S050 2/28/13 135-Day |
Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis, Carpentier-Edwards Duraflex Low Pressure Porcine Mitral Bioprosthesis with Extended Suture Ring |
Edward Lifesciences, LLC Irvine, CA 92614 |
Approval to use an alternate process manufacturing aid to dispense glutaraldehyde. |
P890003/S240 2/28/13 180-Day |
CapSure Pacemaker Leads, Prodigy Implantable Pulse Generators, and Pacemaker Service Repair Kit |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the CapSure Pacemaker Leads, Prodigy Implantable Pulse Generators, and Pacemaker Service Repair Kit. |
P890055/S031 2/12/13 180-Day |
MedStream Programmable Infusion System | Codman & Shurtleff, Incorporated Raynham, MA 02767 |
Approval for modifications to the MedStream Refill Kit and O.R. Prep Kit. The PMA supplement also requested approval for sterilization to occur at Steris Isomedix Services in Northborough, Massachusetts and kit packaging to occur at Contech Medical, Inc., in Providence, Rhode Island. |
P900061/S111 2/28/13 180-Day |
Accessory Upsizing Sleeves, Lead End Pin Cap, and Oval Patch lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Accessory Upsizing Sleeves, Lead End Pin Cap, and Oval Patch lead. |
P910073/S115 2/14/13 Real-Time |
ENDOTAK Reliance IS-1 and 4-SITE Defibrillation Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for labeling changes for the devices. |
P910077/S130 2/12/13 Real-Time |
Multiple Application Utility (MAU) | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for the Multiple Application Utility (MAU), Software Version 8.02. |
P920015/S084 2/28/13 180-Day |
Sprint Quattro Defibrillation Lead Adaptors, Sprint Quattro Defibrillation Leads; Transvene SVC Defibrillation Lead, and Subcutaneous Defibrillation Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Sprint Quattro Defibrillation Lead Adaptors, Sprint Quattro Defibrillation Leads; Transvene SVC Defibrillation Lead, and Subcutaneous Defibrillation Lead. |
P920015/S093 2/13/13 180-Day |
High Voltage Splitter/Adaptor Kit | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 5019 High Voltage Splitter/ Adaptor Kit. |
P930039/S064 2/28/13 180-Day |
CapSure, SureFix, and Vitatron Crystalline ActFix Pacemaker Leads | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the CapSure, SureFix, and Vitatron Crystalline ActFix Pacemaker Leads. |
P940016/S015 2/22/13 Real-Time |
Heparin-Induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Futura Apheresis System |
B. Braun Medical, Inc. Allentown, PA 18109 |
Approval for an increase in membrane length and an increase in housing length of the Heparin Adsorber. The device, as modified, will be marketed under the trade name Heparin Adsorber 400 and is indicated for use as a component of the H.E.L.P Futura Apheresis System, used for the removal, by ionic exchange, of excess heparin added to precipitate lipoproteins from plasma. |
P950024/S038 2/28/13 180-Day |
CapSure Epicardial Pacemaker Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the CapSure Epicardial Pacemaker Lead. |
P950037/S113 12/12/13 Real-Time |
Evia, Entovis, Ecuro, Effecta and Estella Families of Pacemakers | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for three separate modifications to the batteries used in the pulse generators. |
P960016/S040 2/19/13 Real-Time |
Livewire TC Steerable and Safire Steerable Electrophysiology Extension Cables | St. Jude Medical Minnetonka, MN 55345 |
Approval for design modifications to the materials in the extension cables compatible with the Livewire TC Steerable and Safire Steerable Cardiac Ablation Catheters. |
P970003/S154 2/1/13 Real-Time |
VNS Therapy Programming Software and Programming Computer | Cyberonics, Inc. Houston, TX 77058 |
Approval for an upgrade of the programming software to version 10.0, a new programming computer and corresponding adapter cable, and revision of the high impedance threshold. |
P970003/S155 2/25/13 135-Day |
VNS Therapy Pulse/Pulse Duo Generator | Cyberonics, Inc. Houston, TX 77058 |
Approval for a modification to the Electrical Test System (ETS) software used in production. |
D970012/S094 2/6/13 Real-Time |
AMS 700 and Ambicor Inflatable Penile Prosthesis (IPP) | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for the labeling change from 1.5 Tesla (1.5T) Magnetic Resonance Imaging (MRI) strength level to 3.0 Tesla (3.0T) for the bundled AMS products. The devices, as modified, will be marketed under the trade names: 1) AMS 700 and Ambicor Inflatable Penile Prosthesis (IPP) are intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence); 2) AMS 800 Artificial Urinary Sphincter (AUS) treats urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery; and 3) AMS Acticon Neosphincter, Artificial Bowel Sphincter (ABS) is to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for, less invasive forms of restorative therapy. |
P980016/S331 2/28/13 180-Day |
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II, Protecta XT DR, and Protecta DR ICDs |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT, Secura, Virtuoso, Virtuoso II, Protecta XT DR, and Protecta DR ICDs. |
P980016/S389 2/5/13 180-Day |
Virtuoso DR, Virtuoso VR, Virtuoso II DR, Virtuoso II VR, Secura DR, Secura VR, ProtectaXT DR, ProtectaXT VR, Protecta VR |
Medtronic, Inc. Mounds View, MN 55112 |
Approval for clarifications to the indications for use statements related to the OptiVol feature and other modifications to the device labeling. The devices are indicated as follows: Dual Chamber ICDs The <Device Name> DR system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. Notes: 1) The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. 2) The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied. 3) The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to 18.2% in the AF-only patient population studied. Single Chamber ICDs: The <Device Name> VR system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. |
P980018/S016 2/22/13 180-Day |
Hercep Test ™ | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for addition of KADCYLA™ (ado-trastuzumab emtansine) in the labeling of Hercep Test ™. |
P980022/S127 2/20/13 135-Day |
iPro2 Professional Continuous Glucose Monitoring System | Medtronic Minimed Northridge, CA 91325 |
Approval for manufacturing changes to the iPro2 Recorder component of the iPro2 Continuous Glucose Monitoring System that affect the serial and model number assignment tool and the accuracy tester device level tester software. |
P980022/S128 2/11/13 Real-Time |
Paradigm REAL-Time System, Paradigm REAL-Time Revel System Guardian REAL-Time System, CGMS iPro System and iPro2 Professional Continuous Glucose Monitoring System |
Medtronic MiniMed Northridge, CA 91325 |
Approval for a change to the packaging of a Low Dropout (LDO) regulator integrated circuit to Halogen free and a change of the solder plating to pure tin solder plating for the MiniLink REAL-Time Transmitter (MMT-7703), CGMS iPro Recorder (MMT-7709), and iPro2 Recorder (MMT-7741) components of the paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, CGMS iPro, and iPro2 Professional Glucose Monitoring Systems. |
P980022/S129 2/11/13 Real-Time |
Paradigm® REAL-Time Systema and Paradigm® REAL-Time Revel System | Medtronic MiniMed Northridge, CA 91325 |
Approval for substituting the current PVC insulation material of the vibrator motor wiring of the Paradigm REAL-Time and Paradigm REAL-Time Revel insulin pumps (Model numbers: MMT-522, MMT-522K, MMT-523, MMT-523K, MMT-722, MMT-722K, MMT-723, and MMT-723K) with halogen-free material. |
P980023/S049 2/13/13 180-Day |
Linox smart S DX ICD Lead | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the addition of a new model to the Linox smart ICD lead family. This new model will be marketed under the trade name Linox smart S DX ICD lead and indicated for use in the right ventricle of patients for whom implantable cardioverter defibrillators are indicated; it can only be used with the Lumax VR-T DX ICD as a system. The lead incorporates two atrial sensing rings that replace the SVC coil; in addition, an IS-1 connector was added for the atrial sensing rings and the DF-1 connector for the SVC coil was removed. |
P980035/S253 2/28/13 180-Day |
Adapta, Advisa, EnRhythm, Relia, Sensia, and Versa Implantable Pulse Generators | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Adapta, Advisa, EnRhythm, Relia, Sensia, and Versa Implantable Pulse Generators. |
P980035/S270 2/19/13 180-Day |
EnRhythm Implantable Pulse Generator (IPG) | Medtronic, Inc. Mounds View, MN 55112 |
Approval for labeling updates to incorporate the results of the RESPECT post approval study final report, and additional labeling updates. |
P980050/S068 2/28/13 180-Day |
Transvene CS/SVC Defibrillation Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Transvene CS/SVC Defibrillation Lead. |
P000006/S030 2/25/13 Real-Time |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Approval for 1) the addition of a locking nut insert to the narrow rear tip extenders (RTEs); and 2) change in the packaging configuration of this component. |
P000007/S037 2/28/13 135-Day |
Edwards Prima Plus Stentless Porcine Bioprosthesis | Edward Lifesciences, LLC Irvine, CA 92614 |
Approval to use an alternate process manufacturing aid to dispense glutaraldehyde. |
P000021/S023 2/22/13 Real-Time |
Dimension® TPSA Flex® Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 |
Approval for a software revision that changes the operating system of the instrument from the current QNX operating system to the Linux operating system and addresses hardware obsolescence issues. |
P000032/S038 2/6/13 180-Day |
Her Option™ Uterine Croyablation Therapy System™ | Cooper Surgical, Inc. Trumbull, CT 06611 |
Approval for changes to the labeling to reflect the results of the Post-Approval Study. |
P000036/S014 2/28/13 135-Day |
Dermagraft | Shire Regenerative Medicine San Diego, CA 92121 |
Approval for a change in the intra-unit sampling regimen for Dermagraft analytical release assays. |
P000037/S028 2/13/13 180-Day |
On-X Aortic Prosthetic Heart Valve with Anatomic Sewing Ring | On-X Life Technologies, Inc. Austin, TX 78752 |
Approval for a modified aortic sewing cuff as an extension to the line of available valves; the request applied to the aortic sizes of 19, 21, 23, 25, and 27/29 mm. The device, as modified, will be marketed under the trade name On-X Aortic Prosthetic Heart Valve with anatomic Sewing Ring, and will be given the model designations of ONXAN (standard valve holder) and ONXANE (extended valve holder). |
P000053/S047 2/6/13 Real-Time |
AMS 800 Artificial Urinary Sphincter (AUS) | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for the labeling change from 1.5 Tesla (1.5T) Magnetic Resonance Imaging (MRI) strength level to 3.0 Tesla (3.0T) for the bundled AMS products. The devices, as modified, will be marketed under the trade names: 1) AMS 700 and Ambicor Inflatable Penile Prosthesis (IPP) are intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence); 2) AMS 800 Artificial Urinary Sphincter (AUS) treats urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery; and 3) AMS Acticon Neosphincter, Artificial Bowel Sphincter (ABS) is to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for, less invasive forms of restorative therapy. |
P010013/S041 2/1/13 180-Day |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Approval of labeling changes pertaining to the use of NovaSure Impedance Controlled Endometrial Ablation in patients who have micro-inserts from the Essure System for Permanent Birth Control trailing into the endometrial cavity from the Fallopian tubes. |
P010014/S041 2/14/13 180-Day |
Oxford Partial Knee System | Biomet, Inc. Warsaw, IN 46581 |
Approval for a manufacturing site located at Biomet, Inc., in Warsaw, Indiana. |
P010015/S148 2/28/13 180-Day |
Attain, Consulta, and Syncra CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Attain, Consulta, and Syncra CRT-Ps. |
P010015/S162 2/19/13 180-Day |
Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P), Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Approval for labeling updates to incorporate the results of the RESPECT post approval study final report, and additional labeling updates. |
P010020/S027 2/6/13 Real-Time |
AMS Action Neosphincter, Artificial Bowel Sphincter (ABS) | American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for the labeling change from 1.5 Tesla (1.5T) Magnetic Resonance Imaging (MRI) strength level to 3.0 Tesla (3.0T) for the bundled AMS products. The devices, as modified, will be marketed under the trade names: 1) AMS 700 and Ambicor Inflatable Penile Prosthesis (IPP) are intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence); 2) AMS 800 Artificial Urinary Sphincter (AUS) treats urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery; and 3) AMS Acticon Neosphincter, Artificial Bowel Sphincter (ABS) is to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for, less invasive forms of restorative therapy. |
P010031/S284 2/28/13 180-Day |
Concerto, Concerto II, Consulta, InSync III Marquis, InSync Maximo, Maximo II, Protecta, and Protecta XT CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Concerto, Concerto II, Consulta, InSync III Marquis, InSync Maximo, Maximo II, Protecta, and Protecta XT CRT-Ds. |
P010041/S039 2/28/13 135-Day |
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis | Edward Lifesciences, LLC Irvine, CA 92614 |
Approval to use an alternate process manufacturing aid to dispense glutaraldehyde. |
P020012/S007 2/19/13 180-Day |
ArteFill® PMMA Collagen Permanent Dermal Filler | Suneva Medical, Inc. San Diego, CA 92121 |
Approval of the post-approval study protocol. |
P020050/S009 2/21/13 180-Day |
WaveLight® Analyzer II, Accessory to the ALLEGRETTO WAVE® EYE-Q Excimer Laser System | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Approval for the WaveLight® Analyzer II (Model Number 1083), an accessory to the ALLEGRETTO WAVE® Excimer Laser System. |
P030036/S037 2/28/13 180-Day |
Select Secure Pacemaker Leads and Select Secure Anchoring Sleeve | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Select Secure Pacemaker Leads and Select Secure Anchoring Sleeve. |
P030036/S053 2/28/13 Special |
SelectSecure Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for 2 content changes in the SelectSecure Lead Model 3830 technical manual. |
P030054/S236 2/15/13 180-Day |
Quartet™ Left Ventricular Heart Lead with the Promote® Q, Promote® Quadra, or Unify Quadra™ CRT-D |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval of the post- approval study protocol. |
P040005/S009 2/22/13 180-Day |
HER2 IQ-FISH pharmDx™ Kit | Dako Denmark A/S Glostrup, Denmark DK-2600 |
Approval for addition of KADCYLA™ (ado-trastuzumab emtansine) in the labeling of HER2 IQ-FISH pharmDx™ Kit. |
P040024/S065 2/28/13 Real-Time |
Restylane L and Perlane L Injectable Gel | Medicis Aesthetics, Inc. Scottsdale, AZ 85256 |
Approval for a change to the plunger rod for the 2.25 mL syringe for Restylane L and Perlane L Injectable Gel (2 mL fill sizes). |
P050023/S057 2/12/13 Real-Time |
Lumax Family of ICDs and CRT Defibrillators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for three separate modifications to the batteries used in the pulse generators. |
P050028/S029 2/11/13 Real-Time |
COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a new version of cobas p 630 software, v2.2.7. |
P060001/S017 2/12/13 180-Day |
PROTÉGÉ RX Carotid Stent System | ev3, Inc. Plymouth, MN 55441 |
Approval for the addition of the CREATE Post- Approval Study (PAS) results to the Instructions for Use (IFU). |
P060030/S027 2/14/13 180-Day |
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0 |
Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for device design modifications to reduce the sample input volume, improve genotype inclusivity, and improve assay sensitivity to 15 IU/mL. The device, as modified, will be marketed under the trade name COBAS® AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 and is indicated for: The COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test, v2.0 is an in vitro nucleic acid amplification test for the quantitation of Hepatitis C viral (HCV) RNA genotypes 1 to 6 in human EDTA plasma or serum of HCV-infected individuals using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. The test is intended for use in the management of patients with chronic HCV in conjunction with clinical and laboratory markers of infection. The test can be used to predict the probability of sustained virologic response (SVR) early during a course of antiviral therapy, and to assess viral response to antiviral treatment (response guided therapy) as measured by changes of HCV RNA levels in serum or EDTA plasma. Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a plus Ribavirin. No information is available on the assay’s predictive value when other therapies are used. Assay performance for determining the state of HCV infection has not been established. The COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test is not intended for use as a screening test for the presence of HCV in blood or blood products or as a diagnostic test to confirm the presence of HCV infection. |
P060030/S031 2/11/13 Real-Time |
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a new version of cobas p 630 software, v2.2.7. |
P060037/S019 2/20/13 135-Day |
NexGen Complete Knee Solution, Legacy Knee – Posterior Stabilized (LPS), and LPS-Flex Mobile Bearing Knee | Zimmer, Inc. Warsaw, IN 46581 |
Approval for incorporation of a larger transfer basket for the pre-sterilization cleaning process. |
P060039/S031 2/28/13 180-Day |
Attain StarFix Left Ventricular Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Attain StarFix Left Ventricular Lead. |
P070008/S035 2/12/13 Real-Time |
Evia and Entovis Families of CRT Defibrillators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for three separate modifications to the batteries used in the pulse generators. |
P070015/S093 2/1/13 135-Day |
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval for modification of a drug release profile test method. |
P070026/S011 2/19/13 180-Day |
Ceramax Ceramic Total Hip System | DePuy, Inc. Warsaw, IN 46581 |
Approval for the post-approval protocol. |
P080006/S036 2/28/13 180-Day |
Attain Ability, Attain Ability Plus, and Attain Ability Straight Left Ventricular Leads | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the Attain Ability, Attain Ability Plus, and Attain Ability Straight Left Ventricular Leads. |
P080012/S004 2/13/13 Real-Time |
Prometra Programmable Infusion Pump System | Flowonix Medical Incorporated Mount Olive, NJ 07828 |
Approval for a modification to the labeling claim from "MR Unsafe" to "MR Conditional" use. |
P080014/S011 2/4/13 Real-Time |
Cervista® HPV HR Components | Hologic LP Marlborough, MA 01752 |
Approval for shelf-life extension of the devices from 12 months to 18 months. |
P080015/S006 2/4/13 Real-Time |
Cervista® HPV 16/18 Components | Hologic LP Marlborough, MA 01752 |
Approval for shelf-life extension of the devices from 12 months to 18 months. |
P090013/S047 2/28/13 180-Day |
CapSure Fix Pacemaker Lead and Revo MRI Implantable Pulse Generator | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Model 080118 Medical Adhesive used as an accessory for the CapSure Fix Pacemaker Lead and Revo MRI Implantable Pulse Generator. |
P090013/S063 2/19/13 180-Day |
Revo MRI IPG, EnRhythm MRI SureScan IPG | Medtronic, Inc. Mounds View, MN 55112 |
Approval for labeling updates to incorporate the results of the RESPECT post approval study final report, and additional labeling updates. |
P100012/S001 2/6/13 180-Day |
PCM Cervical Disc | NuVasive, Inc. San Diego, CA 92121 |
Approval of the post-approval study protocol. |
P100022/S003 2/15/13 180-Day |
Zilver PTX Drug Eluting Stent | Cook Medical, Inc. Bloomington, IN 47402 |
Approval of the post-approval study protocol. |
P100041/S018 2/28/13 135-Day |
Edwards SAPIEN Transcatheter Heart Valve and Accessories | Edward Lifesciences, LLC Irvine, CA 92614 |
Approval to use an alternate process manufacturing aid to dispense glutaraldehyde. |
P100047/S013 2/27/13 135-Day |
HeartWare Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Approval for addition of an alternate laser welding workstation and to bring a laser marking step in-house. |
P110013/S005 2/22/13 Panel-Track |
Resolute Integrity Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Approval for the Resolute Integrity Zotarolimus-Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length ≤ 35 mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.2 mm. |
P110021/S003 2/28/13 135-Day |
Edwards SAPIEN Transcatheter Heat Valve and Accessories | Edward Lifesciences, LLC Irvine, CA 92614 |
Approval to use an alternate process manufacturing aid to dispense glutaraldehyde. |
P110037/S004 2/11/13 Real-Time |
COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a new version of cobas p 630 software, v2.2.7. |
P110042/S003 2/21/13 Real-Time |
Subcutaneous Implantable Defibrillator S-ICD System | Cameron Health, Inc. San Clemente, CA 92673 |
Approval for Software Maintenance Release (SMR6). |
P110042/S004 2/21/13 Real-Time |
Subcutaneous Implantable Defibrillator S-ICD System | Cameron Health, Inc. San Clemente, CA 92673 |
Approval for a change to the patient screening instructions in the SQ-RX Pulse Generator User Manual. |
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 |
---|---|---|---|
N18033/S068 2/27/13 |
VISTAKON (etafilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Implementation of an alternate injection molding machine. |
P830061/S085 2/7/13 |
CapSure Sense Bipolar Lead | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing changes at the Medtronic Singapore Operations (MSO) manufacturing facility: Proteus 3.6 and Self-Test 3.3 final function testier update, SQM version 3.3.3, FactoryWorks Version 7.8, AATS Version 5.0 update, and Thermal processing of epoxy resin. |
P840001/S232 2/14/13 |
Itrel 4 Neurostimulator, Itrel 3 Neurostimulator, Synergy Neurostimulator, Synergy Versitrel Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change to the connector cleaning technology process. |
P840001/S233 2/25/13 |
SCS Neurostimulators, SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore Family | Medtronic, Inc. Minneapolis, MN 55432 |
Update to the LTX Test System Shell Software. |
P850048/S031 2/6/13 |
Access Hybritech PSA Reagents on the Access Immunoassay System | Beckman Coulter, Inc. Chaska, MN 55318 |
Change to the Special Clean maintenance procedure that mitigates Vitamin B 12 carryover from a wash buffer/ methanol combination to a methanol/DI combination and also to use ethanol and methanol interchangeably as part of the Special Clean maintenance procedure. This Special Clean procedure would be used with the Access AFP, Hybritech Free PSA, Hybritech PSA and Hybritech p2PSA reagents on the Access, Access 2, Synchron LXi 725, and UniCel DxC 600i Integrated Clinical Systems. |
P860003/S070 2/19/13 |
CELLEX Procedural Kit | Therakos, Inc. Raritan, NJ 08869 |
Manufacturing process change to apply a currently used UV curable adhesive in an additional location within the CellEx Photopheresis Procedural Kit. |
P860004/S186 2/25/13 |
Drug Deliver Infusion Pumps SynchroMed Family | Medtronic, Inc. Minneapolis, MN 55432 |
Update to the LTX Test System Shell Software. |
P860057/S103 2/14/13 |
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 |
Use of parametric release in the manufacture of several models of the Carpentier-Edwards Perimount Aortic and Mitral Valve Bioprostheses. |
P890003/S262 2/8/13 |
CareLink Monitor, CardioSight Reader | Medtronic, Inc. Mounds View, MN 55112 |
Additional in-process inspection of the hybrid cathode mix ratio, new pressure test equipment, new manufacturing lines in an extended controlled environment area, CMOS process flow changes, an update to test software and hardware for integrated circuits, the implementation of FACTORYworks Release 8.0 and MES Web Services Release 2.1, and updates to the IC wafer probe test specifications and test software. |
P900056/S120 2/14/13 |
Rotablator Rotational Atherectomy System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the temperature of the sterilization cycle. |
P910001/S064 2/28/13 |
ELCA Coronary Atherectomy Catheters | Spectranetics Corporation Colorado Springs, CO 80921 |
Change to the process for monitoring the ethylene oxide sterilization process. |
P910023/S313 2/25/13 |
Current+, Epic II/ Epic II+, Fortify, Fortify Assura, Ellipse ICD Devices | St. Jude Medical CRMD Sylmar, CA 91341 |
Alternate supplier for encapsulation material. |
P920047/S055 2/22/13 |
EPT-1000 Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Automate the temperature, humidity, and differential pressure monitoring system at the Heredia, Costa Rica facility. |
P930031/S041 2/14/13 |
Wallstent (TIPS) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a rework step in the electro etch process. |
P930039/S082 2/7/12 |
CapSureFix Novus Leads | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing changes at the Medtronic Singapore Operations (MSO) manufacturing facility: Proteus 3.6 and Self-Test 3.3 final function testier update, SQM version 3.3.3, FactoryWorks Version 7.8, AATS Version 5.0 update, and Thermal processing of epoxy resin. |
P950020/S060 2/12/13 |
Coronary Flextome Cutting Balloon | Boston Scientific Corporation Maple Grove, MN 55311 |
Alternate inspection equipment for the extruded tubing component. |
P950037/S118 2/19/13 |
Evia DR, DR-T, SR, SR-T, Entovis DR, DR-T, Entovis SR, SR-T, Estella DR, Estella DR-T, Estella SR, SR-T, Ecuro Dr, DR-T, SR, SR-T, Effecta D, DR, S, SR Pulse Generators, Kainox VCS non-steroid Pacing Lead, Setrox ST 53, Setrox ST 60, Setrox S 45, Setrox S 53, Setrox S 60 Corox OTW 75 UP, Dextrus 4138 Tilda R45 Permanent Pacing/Defibrillator Steroid Leads | Biotronik, Inc. Lake Oswego, OR 97035 |
Reclassifying the environmental conditions from Class D to ISO 8 cleanrooms. |
P960009/S162 2/14/13 |
Activa SC Neurostimulator, Soletra Neurostimulator, Kinetra Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change to the connector cleaning technology process. |
P960009/S163 2/26/13 |
Medtronic Activa Tremor Control System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Implementation of a new inspection process to verify the distal end surface straightness of DBS leads. |
P960009/S164 2/25/13 |
DBS Neurostimulators External, DBS Neurostimulators Implantable Activa Family | Medtronic, Inc. Minneapolis, MN 55432 |
Update to the LTX Test System Shell Software. |
P960040/S285 2/8/13 |
Punctua VR IS4, Punctua VR DF1, Punctua DR IS4, Punctua DR DF1, Energen VR IS4, Energen VR DF1 Energen DR IS4, Energen DR DFl, Incepta VR IS4 Incepta VR DF1, Incepta DR IS4, Incepta DR DF1 | Boston Scientific, Inc. St. Paul, MN 55112 |
Approval of additional spotweld equipment. |
P960040/S286 2/20/13 |
Incepta, Energen, Punctua and Teligen ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the designation of the anode foil chloride content specification from the design specification to the performance specification. |
P960042/S046 2/28/13 |
SLSII and GlideLight Laser Sheaths | Spectranetics Corporation Colorado Springs, CO 80921 |
Change to the process for monitoring the ethylene oxide sterilization process. |
P970003/S156 2/7/13 |
VNS Therapy Generators | Cyberonics, Inc. Houston, TX 77058 |
Manufacturing change for the therapy generators. |
P970004/S148 2/14/13 |
SNS Urinary Neurostimulator Implantable InterStim Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Alternate suppliers for the Integrated Circuit for the InterStim II Implantable Neurostimulator. |
P970004/S149 2/14/13 |
Interstim Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change to the connector cleaning technology process. |
P970038/S020 2/6/13 |
Access Hybritech Free PSA Reagents on the Access Immunoassay System | Beckman Coulter, Inc. Chaska, MN 55318 |
Change to the Special Clean maintenance procedure that mitigates Vitamin B 12 carryover from a wash buffer/ methanol combination to a methanol/DI combination and also to use ethanol and methanol interchangeably as part of the Special Clean maintenance procedure. This Special Clean procedure would be used with the Access AFP, Hybritech Free PSA, Hybritech PSA and Hybritech p2PSA reagents on the Access, Access 2, Synchron LXi 725, and UniCel DxC 600i Integrated Clinical Systems. |
P980016/S395 2/7/13 |
Maximo II, Protecta, Protecta XT, Secura, and Virtuoso II DR/VR ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Acceptance of an upgrade to Test System Software Shell. |
P980023/S051 2/19/13 |
Kainox VCS, Linox S, T, SO, TO, LinoxSmart S, T, SO, TD, Selox JT 45, Selox JT 53 Permanent Pacing/ Defibrillator Steroid Leads | Biotronik, Inc. Lake Oswego, OR 97035 |
Reclassifying the environmental conditions from Class D to ISO 8 cleanrooms. |
P980024/S010 2/11/13 |
PathVysion HER-2 DNA Probe Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Addition of an alternate supplier for Human Placental (HP) DNA which is a component of the PathVysion HER-2 DNA Probe Kit and the UroVysion Bladder Cancer Kit. |
P980033/S030 2/14/13 |
Wallstent (Venous) Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a rework step in the electro etch process. |
P980035/S294 2/8/13 |
Advisa DR MRI | Medtronic, Inc. Mounds View, MN 55112 |
Additional in-process inspection of the hybrid cathode mix ratio, new pressure test equipment, new manufacturing lines in an extended controlled environment area, CMOS process flow changes, an update to test software and hardware for integrated circuits, the implementation of FACTORYworks Release 8.0 and MES Web Services Release 2.1, and updates to the IC wafer probe test specifications and test software. |
P980035/S303 2/7/13 |
Adapta/Versa/ Sensia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Manufacturing changes at the Medtronic Singapore Operations (MSO) manufacturing facility: Proteus 3.6 and Self-Test 3.3 final function testier update, SQM version 3.3.3, FactoryWorks Version 7.8, AATS Version 5.0 update, and Thermal processing of epoxy resin. |
P980035/S304 2/7/13 |
Adapta, Versa, Sensia, Advisa DR and Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Acceptance of an upgrade to Test System Software Shell. |
P980035/S305 2/26/13 |
Adapta, Adapta L, Adapta S, Sensia, Sensia L, Versa and Relia Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Change to the component injection molding process for the connector module. |
P980035/S306 2/27/13 |
Advisa DR and Advisa MRI IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the Accelerometer Activity Test System. |
P980041/S021 2/6/13 |
Access AFP Reagents on the Access Immunoassay System | Beckman Coulter, Inc. Chaska, MN 55318 |
Change to the Special Clean maintenance procedure that mitigates Vitamin B 12 carryover from a wash buffer/ methanol combination to a methanol/DI combination and also to use ethanol and methanol interchangeably as part of the Special Clean maintenance procedure. This Special Clean procedure would be used with the Access AFP, Hybritech Free PSA, Hybritech PSA and Hybritech p2PSA reagents on the Access, Access 2, Synchron LXi 725, and UniCel DxC 600i Integrated Clinical Systems. |
P000006/S031 2/14/13 |
Titan Inflatable Penile Prosthesis System | Coloplast Corporation Minneapolis, MN 55411 |
Replacement of existing testing equipment used in the manufacturing process of the device. |
P000006/S032 2/21/13 |
Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corporation Minneapolis, MN 55411 |
Use a new piece of equipment in the manufacturing drying process. |
P000054/S036 2/7/13 |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Extension of the expiry of batch reference material. |
P000054/S037 2/13/13 |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Addition of an alternative water supplier. |
P000058/S051 2/7/13 |
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion | Medtronic Sofamor Danek Memphis, TN 38132 |
Extension of the expiry of batch reference material. |
P000058/S052 2/13/13 |
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion | Medtronic Sofamor Danek Memphis, TN 38132 |
Addition of an alternative water supplier. |
P010012/S320 2/8/13 |
Energen CRT-D IS4, Energen CRT-D DF4, Punctua CRT-D IS4, Punctua CRT-D DFl/ISl, Incepta CRT-D IS4, Incepta CRT-D DF1/IS1, Incepta CRT-D DF1//LVl |
Boston Scientific, Inc. St. Paul, MN 55112 |
Approval of additional spotweld equipment. |
P010012/S321 2/20/13 |
Incepta, Energen, Punctua and Cognis CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Change in the designation of the anode foil chloride content specification from the design specification to the performance specification. |
P010015/S187 2/7/13 |
Consulta and Syncra CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Acceptance of an upgrade to Test System Software Shell. |
P010015/S188 2/27/13 |
Consulta and Syncra CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the Accelerometer Activity Test System. |
P010031/S345 2/7/13 |
Concerto II, Maximo II, Protecta, and Protecta XT CRT-Ds, Consulta DF4 and Consulta ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Acceptance of an upgrade to Test System Software Shell. |
P010031/S346 2/25/13 |
Viva S CRT-D, Viva XT CRT-D and Brava CRT-D Family of Devices | Medtronic CRDM Mounds View, MN 55112 |
Update to the acceptance criterion for percent delamination on all die. |
P010031/S347 2/2513 |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic CRDM Mounds View, MN 55112 |
Addition of a specific criterion to allow delamination for the lower wire bond pad on the U31 FET. |
P010031/S348 2/28/13 |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic CRDM Mounds View, MN 55112 |
Change to the current drain related limits for an IC to prevent excessive yield fallout. |
P010031/S349 2/28/13 |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic CRDM Mounds View, MN 55112 |
Two process adjustment changes for the integrated circuit at a Medtronic supplier. |
P010031/S351 2/28/13 |
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D | Medtronic CRDM Mounds View, MN 55112 |
Update to the Automated Test Equipment software that tests an IC to improve manufacturing yields. |
P010031/S352 2/28/13 |
Viva S CRT-D, Viva XT CRT-D and Brava CRT-D | Medtronic CRDM Mounds View, MN 55112 |
Implementation of additional tooling for the case liner assembly manufacturing process. |
P010031/S355 2/28/13 |
Viva S CRT-D, Viva XT CRT-D and Brava CRT-D Family of Devices | Medtronic CRDM Mounds View, MN 55112 |
Change to the hybrid burn-in time. |
P020009/S102 2/14/13 |
Express Monorail and OTW Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the extrusion melt filter. |
P020025/S038 2/22/13 |
EPT-1000 XP RF Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Automate the temperature, humidity, and differential pressure monitoring system at the Heredia, Costa Rica facility. |
P030017/S153 2/26/13 |
Precision Spinal Cord Stimulator System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Laser marking the serial number on the retention sleeve. |
P030052/S011 2/11/13 |
UroVysion Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Addition of an alternate supplier for Human Placental (HP) DNA which is a component of the PathVysion HER-2 DNA Probe Kit and the UroVysion Bladder Cancer Kit. |
P030054/S243 2/25/13 |
Promote+, Unify, Unify Quadra, Quadra Assura CRT-D Devices | St. Jude Medical CRMD Sylmar, CA 91341 |
Alternate supplier for encapsulation material. |
P040016/S107 2/14/13 |
VeriFlex (Liberté) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the extrusion melt filter. |
P040016/S108 2/20/13 |
VeriFlex (Liberté) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new extrusion equipment. |
P040024/S066 2/28/13 |
Restylane Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Proposed modification to the autoclave requalification strategy in Factory 1 and Factory 2. |
P040045/S036 2/27/13 |
VISTAKON (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Implementation of an alternate injection molding machine. |
P050023/S060 2/19/13 |
Lumax 300 DR-T, Lumax 340 DR-T, Lumax 300 VR-T, Lumax 500 DRT, Lumax 540 DR-T, Lumax 500 VR-T, Lumax 540 VR-T, Lumax 600 DR-T, VR-T, Lumax 640 DR-T, VR-T, Lumax 640 VR-T DX, Lumax 700 VR-T, Lumax 740 DR-T, VR-T, Lumax 740 VR-T DX ICDs, Luma~ 300 HF-T, Lumax 340 HF-T, Lumax 500 HF-T, Lumax 540 HF-T, Lumax 600 HF-T, Lumax 640 HF-T, Lumax 700 HF-T, Lumax 740 HF-T CRTDs, Corox OTW 75 UP Steroid, Corox OTW 85 UP Permanent Pacing/Defibrillator Steroid Leads, Corox OTW 75-BP, Corox OTW 85 BP Leads | Biotronik, Inc. Lake Oswego, OR 97035 |
Reclassifying the environmental conditions from Class D to ISO 8 cleanrooms. |
P050037/S035 2/22/13 |
Radiesse Injectable Implant | Merz Aesthetics, Inc. Franksville, WI 53126 |
New raw material suppliers. |
P050039/S015 2/7/13 |
Exactech® Novation Ceramic Articulation Hip System (AHS) | Exactech, Inc. Gainesville, FL 32653 |
Additional manufacturing equipment. |
P050052/S038 2/22/13 |
Radiesse Injectable Implant | Merz Aesthetics, Inc. Franksville, WI 53126 |
New raw material suppliers. |
P050053/S028 2/7/13 |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Extension of the expiry of batch reference material. |
P050053/S029 2/13/13 |
INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 |
Addition of an alternate water supplier. |
P060001/S019 2/27/13 |
Protégé GPS/RX Carotid Stent Systems | eV3 Plymouth, MN 55441 |
Addition of alternate supplier for raw nitinol tubing. |
P060006/S040 2/14/13 |
Express SD Renal Monorail Premounted Stent Systems | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the extrusion melt filter. |
P060006/S041 2/20/13 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new extrusion equipment. |
P070008/S038 2/19/13 |
Stratos LV, Evia HF, HF-T, Entovis HF, HF-T CRT-Ps, Corox OTW-S 75 BP, Corox OTW-S 85-BP, Corox OTW-L 75-BP, Corox OTW-L 85-BP Steroid Pacing/ Defibrillator Leads | Biotronik, Inc. Lake Oswego, OR 97035 |
Reclassifying the environmental conditions from Class D to ISO 8 cleanrooms. |
P070015/S106 2/20/13 |
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92589 |
Shorten the shelf-life of a solvent used for the manufacturing of the devices. |
P080025/S044 2/14/13 |
SNS Bowel Neurostimulator Implantable InterStim Family | Medtronic Neuromodulation Minneapolis, MN 55432 |
Alternate suppliers for the Integrated Circuit for the InterStim II Implantable Neurostimulator. |
P080025/S045 2/14/13 |
Interstim Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Change to the connector cleaning technology process. |
P080026/S005 2/7/13 |
Abbott Real Time HBV | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Change to the existing label print and inspection equipment with 2 new label printers, new label printing software, and a new label inspection system that is used to print and inspect labels for all manufactured parts at Abbott Molecular Inc. in Des Plaines, Illinois. |
P090013/S082 2/7/13 |
CapSureFix MRI SureScan Lead | Medtronic, Inc. Mounds View, MN 55112 |
Multiple manufacturing changes for the Medtronic Singapore Operations (MSO) manufacturing facility. |
P090013/S083 2/7/13 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Acceptance of an upgrade to Test System Software Shell. |
P090016/S005 2/14/13 |
Belotero Balance | Merz Aesthetics, Inc. Franksville, WI 53126 |
New evaluation process for Out of Specification results. |
P090022/S015 2/26/13 |
Softec HDO Intraocular Lens | Lenstec Inc. St. Petersburg, FL 33716 |
Additional lens analyzer. |
P090026/S004 2/6/13 |
Access Hybritech p2PSA Reagents on the Access Immunoassay System | Beckman Coulter, Inc. Chaska, MN 55318 |
Change to the Special Clean maintenance procedure that mitigates Vitamin B 12 carryover from a wash buffer/ methanol combination to a methanol/DI combination and also to use ethanol and methanol interchangeably as part of the Special Clean maintenance procedure. This Special Clean procedure would be used with the Access AFP, Hybritech Free PSA, Hybritech PSA and Hybritech p2PSA reagents on the Access, Access 2, Synchron LXi 725, and UniCel DxC 600i Integrated Clinical Systems. |
P100023/S068 2/14/13 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Natick, MA 01760 |
Use of an alternate in-process inspection. |
P100040/S010 2/28/13 |
Valiant Thoracic Stent Graft with the Captivia Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Use of an alternate testing fixture and alternate test procedure. |
P100041/S021 2/8/13 |
Edwards SAPIEN Transcatheter Heart Valve and Transfemoral Accessories |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Changes affecting the suppliers of the raw materials for polypropylene monofilament thread, polyethylene terephthalate woven ribbon, and vestamid resin. |
P100044/S007 2/27/13 |
Propel and Propel Mini Sinus Implant | Intersect ENT Menlo Park, CA 94025 |
Changes to two quality control test methods. |
P100047/S015 2/19/13 |
Heartware Ventricular Assist System | Heartware, Inc. Miami Lakes, FL 33014 |
Installation of a new label printer. |
P110010/S045 2/14/13 |
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Natick, MA 01760 |
Use of an alternate in-process inspection. |
P110010/S046 2/21/13 |
Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of software controls to the secondary pack sealer. |
P110010/S047 2/21/13 |
Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software and hardware upgrades to the Integrated Crimp and Cone Puff machines. |
P110019/S040 2/20/13 |
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92589 |
Shorten the shelf-life of a solvent used for the manufacturing of the devices. |
P110021/S007 2/8/13 |
Edwards SAPIEN Transcatheter Heart Valve and Transfemoral and Transapical Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Changes affecting the suppliers of the raw materials for polypropylene monofilament thread, polyethylene terephthalate woven ribbon, and vestamid resin. |
P110028/S007 2/12/13 |
Absolute Pro Vascular Self- Expanding Stent System | Abbott Vascular Temecula, CA 92590 |
Align clean room action limits with a new standard. |
P110035/S006 2/20/13 |
Epic Vascular Self-Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of new extrusion equipment. |
P110035/S007 2/20/13 |
Epic Vascular Self-Expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Process change within the expansion and heat setting process for the Epic Stents. |