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U.S. Department of Health and Human Services

Medical Devices

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February 2013 PMA Approvals

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
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 SystemLombard 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N16837/S010
2/25/13
135-Day
Artegraft Collagen Vascular GraftArtegraft 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 SystemEBI, 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 TechnologySt. 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 leadsMedtronic, 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 leadsMedtronic, 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 SystemsTHERAKOS, 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 SystemCodman & 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 leadMedtronic, 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 LeadsBoston 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 LeadMedtronic, 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 KitMedtronic, 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 LeadsMedtronic, 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 LeadMedtronic, 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 PacemakersBiotronik, 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 CablesSt. 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 ComputerCyberonics, 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 GeneratorCyberonics, 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 SystemMedtronic 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 SystemMedtronic 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 LeadBiotronik, 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 GeneratorsMedtronic, 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 LeadMedtronic, 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 ProsthesisColoplast 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 BioprosthesisEdward 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 CartridgeSiemens 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
DermagraftShire 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 RingOn-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 SystemHologic, 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 SystemBiomet, 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-PsMedtronic, 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-PMedtronic, 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-DsMedtronic, 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 BioprosthesisEdward 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 FillerSuneva 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 SystemAlcon 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 SleeveMedtronic, 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 LeadMedtronic, 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™ KitDako 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 GelMedicis 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 DefibrillatorsBiotronik, 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, v2.0Roche 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 Systemev3, 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 TestRoche 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 KneeZimmer, 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 LeadMedtronic, 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 DefibrillatorsBiotronik, 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 SystemAbbott 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 SystemDePuy, 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 LeadsMedtronic, 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 SystemFlowonix 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 ComponentsHologic 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 ComponentsHologic 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 GeneratorMedtronic, 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 IPGMedtronic, 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 DiscNuVasive, Inc.
San Diego, CA
92121
Approval of the post-approval study protocol.
P100022/S003
2/15/13
180-Day
Zilver PTX Drug Eluting StentCook 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 AccessoriesEdward 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 SystemHeartWare, 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 SystemMedtronic 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 AccessoriesEdward 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 TestRoche 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 SystemCameron Health, Inc.
San Clemente, CA
92673
Approval for Software Maintenance Release (SMR6).
P110042/S004
2/21/13
Real-Time
Subcutaneous Implantable Defibrillator S-ICD SystemCameron 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N18033/S068
2/27/13
VISTAKON (etafilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Implementation of an alternate injection molding machine.
P830061/S085
2/7/13
CapSure Sense Bipolar LeadMedtronic, 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 NeurostimulatorMedtronic 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 FamilyMedtronic, 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 SystemBeckman 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 KitTherakos, 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 FamilyMedtronic, 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 ReaderMedtronic, 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 SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the temperature of the sterilization cycle.
P910001/S064
2/28/13
ELCA Coronary Atherectomy CathetersSpectranetics 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 DevicesSt. Jude Medical CRMD
Sylmar, CA
91341
Alternate supplier for encapsulation material.
P920047/S055
2/22/13
EPT-1000 Cardiac Ablation SystemBoston 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) EndoprosthesisBoston Scientific Corporation
Maple Grove, MN
55311
Addition of a rework step in the electro etch process.
P930039/S082
2/7/12
CapSureFix Novus LeadsMedtronic, 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 BalloonBoston 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 LeadsBiotronik, 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 NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN
55432
Change to the connector cleaning technology process.
P960009/S163
2/26/13
Medtronic Activa Tremor Control SystemMedtronic 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 FamilyMedtronic, 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 DF1Boston Scientific, Inc.
St. Paul, MN
55112
Approval of additional spotweld equipment.
P960040/S286
2/20/13
Incepta, Energen, Punctua and Teligen ICDsBoston 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 SheathsSpectranetics Corporation
Colorado Springs, CO
80921
Change to the process for monitoring the ethylene oxide sterilization process.
P970003/S156
2/7/13
VNS Therapy GeneratorsCyberonics, Inc.
Houston, TX
77058
Manufacturing change for the therapy generators.
P970004/S148
2/14/13
SNS Urinary Neurostimulator Implantable InterStim FamilyMedtronic Neuromodulation
Minneapolis, MN
55432
Alternate suppliers for the Integrated Circuit for the InterStim II Implantable Neurostimulator.
P970004/S149
2/14/13
Interstim NeurostimulatorMedtronic 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 SystemBeckman 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 ICDsMedtronic, 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 LeadsBiotronik, 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 KitAbbott 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) EndoprosthesisBoston Scientific Corporation
Maple Grove, MN
55311
Addition of a rework step in the electro etch process.
P980035/S294
2/8/13
Advisa DR MRIMedtronic, 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 IPGMedtronic, 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 IPGsMedtronic, 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 IPGsMedtronic, 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 IPGsMedtronic, Inc.
Mounds View, MN
55112
Changes to the Accelerometer Activity Test System.
P980041/S021
2/6/13
Access AFP Reagents on the Access Immunoassay SystemBeckman 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 SystemColoplast 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 GraftMedtronic Sofamor Danek
Memphis, TN
38132
Extension of the expiry of batch reference material.
P000054/S037
2/13/13
INFUSE® Bone GraftMedtronic Sofamor Danek
Memphis, TN
38132
Addition of an alternative water supplier.
P000058/S051
2/7/13
INFUSE® Bone Graft/LT-Cage Lumbar Tapered FusionMedtronic 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 FusionMedtronic 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-DsBoston 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-PsMedtronic, Inc.
Mounds View, MN
55112
Acceptance of an upgrade to Test System Software Shell.
P010015/S188
2/27/13
Consulta and Syncra CRT-PsMedtronic, 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 ICDsMedtronic, 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 DevicesMedtronic 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-DMedtronic 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-DMedtronic 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-DMedtronic 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-DMedtronic 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-DMedtronic 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 DevicesMedtronic CRDM
Mounds View, MN
55112
Change to the hybrid burn-in time.
P020009/S102
2/14/13
Express Monorail and OTW Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the extrusion melt filter.
P020025/S038
2/22/13
EPT-1000 XP RF Ablation SystemBoston 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 SystemBoston Scientific Neuromodulation
Valencia, CA
91355
Laser marking the serial number on the retention sleeve.
P030052/S011
2/11/13
UroVysion Bladder Cancer KitAbbott 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 DevicesSt. Jude Medical CRMD
Sylmar, CA
91341
Alternate supplier for encapsulation material.
P040016/S107
2/14/13
VeriFlex (Liberté) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the extrusion melt filter.
P040016/S108
2/20/13
VeriFlex (Liberté) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new extrusion equipment.
P040024/S066
2/28/13
Restylane Injectable GelMedicis 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 LensesJohnson & 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 LeadsBiotronik, Inc.
Lake Oswego, OR
97035
Reclassifying the environmental conditions from Class D to ISO 8 cleanrooms.
P050037/S035
2/22/13
Radiesse Injectable ImplantMerz 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 ImplantMerz Aesthetics, Inc.
Franksville, WI
53126
New raw material suppliers.
P050053/S028
2/7/13
INFUSE® Bone GraftMedtronic Sofamor Danek
Memphis, TN
38132
Extension of the expiry of batch reference material.
P050053/S029
2/13/13
INFUSE® Bone GraftMedtronic Sofamor Danek
Memphis, TN
38132
Addition of an alternate water supplier.
P060001/S019
2/27/13
Protégé GPS/RX Carotid Stent SystemseV3
Plymouth, MN
55441
Addition of alternate supplier for raw nitinol tubing.
P060006/S040
2/14/13
Express SD Renal Monorail Premounted Stent SystemsBoston Scientific Corporation
Maple Grove, MN
55311
Change to the extrusion melt filter.
P060006/S041
2/20/13
Express SD Renal Monorail Premounted Stent SystemBoston 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 LeadsBiotronik, 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 SystemAbbott 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 FamilyMedtronic Neuromodulation
Minneapolis, MN
55432
Alternate suppliers for the Integrated Circuit for the InterStim II Implantable Neurostimulator.
P080025/S045
2/14/13
Interstim NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN
55432
Change to the connector cleaning technology process.
P080026/S005
2/7/13
Abbott Real Time HBVAbbott 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 LeadMedtronic, Inc.
Mounds View, MN
55112
Multiple manufacturing changes for the Medtronic Singapore Operations (MSO) manufacturing facility.
P090013/S083
2/7/13
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Acceptance of an upgrade to Test System Software Shell.
P090016/S005
2/14/13
Belotero BalanceMerz Aesthetics, Inc.
Franksville, WI
53126
New evaluation process for Out of Specification results.
P090022/S015
2/26/13
Softec HDO Intraocular LensLenstec Inc.
St. Petersburg, FL
33716
Additional lens analyzer.
P090026/S004
2/6/13
Access Hybritech p2PSA Reagents on the Access Immunoassay SystemBeckman 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 SystemBoston Scientific
Natick, MA
01760
Use of an alternate in-process inspection.
P100040/S010
2/28/13
Valiant Thoracic Stent Graft with the Captivia Delivery SystemMedtronic 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 ImplantIntersect ENT
Menlo Park, CA
94025
Changes to two quality control test methods.
P100047/S015
2/19/13
Heartware Ventricular Assist SystemHeartware, 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 SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemAbbott 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 AccessoriesEdwards 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 SystemAbbott Vascular
Temecula, CA
92590
Align clean room action limits with a new standard.
P110035/S006
2/20/13
Epic Vascular Self-Expanding Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Use of new extrusion equipment.
P110035/S007
2/20/13
Epic Vascular Self-Expanding Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Process change within the expansion and heat setting process for the Epic Stents.

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