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U.S. Department of Health and Human Services

Medical Devices

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May 2012 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

None.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N16837/S009
5/11/12
135-Day
Artegraft Collagen Vascular Graft Artegraft, Inc.
North Brunswick, NJ
08902
Approval for the addition of an alternate supplier of a major component for the manufacturing of the device.
P810025/S028
5/15/12
180-Day
Amvisc® and Amvisc® Plus Ophthalmic Viscosurgical Devices (OVD) Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval for an alternate raw material source (Lifecore's fermentation-based
sodium hyaluronate) and alternate manufacturing site (Lifecore Biomedical, LLC, Chaska, MN)
for the raw material and finished products.
P840001/S208
5/24/12
Real-Time
RestoreSensor Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for minor design changes to the L283 multi- function integrated circuit contained in the neurostimulator of the RestoreSensor Neurostimulator, Model 37714.
P840001/S211
5/30/12
Real-Time
Itrel 4 Implantable Neurostimulation System Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for Itrel 4 neurostimulators, Models 37703 and 37704. The devices, as modified, will be marketed under the trade names Itrel 4 neurostimulators, Models 37703 and 37704 and are indicated as an aid in the management of chronic, intractable pain of
the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions:
1) Failed Back Syndrome (FBS) or low back syndrome or failed back;
2) Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk;
3) Postlaminectomy pain; 4) Multiple back operations;
5) Unsuccessful disk surgery;
6) Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions;
7) Peripheral causalgia;
8) Epidural fibrosis;
9) Arachnoiditis or lumbar adhesive arachnoiditis;
10) Complex Regional Pain Syndrome (CRPS);
11) Reflex Sympathetic Dystrophy (RSD), or 11) Causalgia.
P860004/S125
5/2/12
180-Day
Ascenda Catheter Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for the Ascenda Catheter, which consists of two models (8780 and 8781) that are identical in components and accessories and differ only in their total length. This catheter differs from the current intrathecal catheters used with Medtronic Implantable pumps by the following modifications:
1) Multi-layered catheter body that resists cuts, fractures, and occlusions;
2) Bi-wing anchor with new anchor dispenser designed to prevent catheter dislodgment;
3) Catheter connector that prevents puncture of the catheter body; and
4) Modified sutureless pump connector design to prevent occlusion.
P860047/S024
5/4/12
135-Day
OcuCoat (2% Hydroxypropyl-methylcellulose Solution Bausch and Lomb Incorporated
Rochester, NY
14609
Approval for a manufacturing site located at Lifecore Biomedical, LLC in Chaska, Minnesota.
P880006/S075
5/7/12
180-Day
Sensolog, Dialog, Regency Family of Pacemakers St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for lead failure detection and telemetry enhancements.
P880086/S211
5/7/12
180-Day
Affinity, Integrity, Victory, Zephyr, Accent Family of Pacemakers St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for lead failure detection and telemetry enhancements.
P890003/214
5/2/12
180-Day
Medtronic CareLink Monitor, Cardio- Sight® Reader and
DDMA
Medtronic, Inc.
Mounds View, MN
55112
Approval for Medtronic CareLink Monitor Model 2490C, CardioSight® Reader Model 2020A, and
Model 2491 DDMA.
P890064/S027
5/21/12
180-Day
Hybrid Capture 2 (HC2) HPV DNA Test and Hybrid Capture 2 (HC2) High Risk HPV DNA Test QIAGEN Gaithersburg, Inc.
Gaithersburg, MD
20878
Approval for a manufacturing site located at QIAGEN Instruments AG in Hombrechtikon, Switzerland.
P900033/S020
5/4/12
180-Day
Integra Artificial Skin, Dermal Regeneration Template, Integra Dermal Regeneration Template – Terminally Sterilized (IDRT-ts) Integra LifeSciences Corporation
Plainsboro, NJ
08536
Approval for a manufacturing site located at Integra Neurosciences in Anasco, Puerto Rico.
P900033/S021
5/24/12
180-Day
Integra Dermal Regeneration Template – Terminally Sterilized (IDRT-ts) Integra LifeSciences Corporation
Plainsboro, NJ
08536
Approval for a manufacturing site located at Synergy Health AST, LLC in Denver, Colorado.
P910018/S015
5/3/12
180-Day
Liposorber® LA-15 System Kaneka Pharma America, LLC
New York, NY
10036
Approval for modifications to the Sulflux® KP-05 plasma separator component of the device.
P910023/S279
5/7/12
180-Day
Cadence, Ellipse, Fortify Assura Family of ICDs St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for lead failure detection and telemetry enhancements.
P910023/S285
5/10/12
180-Day
Angstrom II/MD, Atlas/Atlas+, Atlas II/Atlas II+, Cadence, Cadet, Contour, Contour II/MD, Current, Current Accel, Convert/Convert+, Current +, Current RF, Epic/Epic+, Epic II/Epic II+, Fortify, Photon, Photon Micro and Profile II/MD St. Jude Medical, Inc.
Sylmar, CA
91392
Approval for a manufacturing site located at St. Jude Medical Operations Malaysia (SJM-MYPE) in Penang, Malaysia.
P910056/S010
5/30/12
180-Day
enVista One-Piece Hydrophobic Acrylic Intraocular Lens Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval for a material change and design modifications (3-piece to 1-piece design and aspheric surface) to the approved Bausch & Lomb silicone lens C31UB. The device, as modified, will be marketed under the trade name enVista One-Piece Hydrophobic Acrylic Intraocular Lens, Model MX60 and is indicated for primary implantation for the visual correction of aphakia in adult patients in whom the cataractous crystalline lens has been removed.
P940015/S025
5/3/12
135-Day
Synvisc® and Synvisc-One® Genzyme Corporation
Cambridge, MA
02142
Approval for the addition of a new product data and laboratory information management system.
P950020/S048
5/9/12
135-Day
Coronary Flextome Cutting Balloon Boston Scientific Corporation
Maple Grove, MN
55311
Approval for the use of an alternate moisture analyzer.
P950022/S078
5/24/12
Real-Time
Durata Defibrillation Leads St. Jude Medical, CRMD
Sylmar, CA
91342
Approval for a modification to the DF-1 connector region of the Durata defibrillation leads.
P950037/S084
5/8/12
180-Day
Reocor S/D Family of External Pacemakers Biotronik, Inc.
Lake Oswego, OR
97035
Approval for two new families of temporary external pacemaker pulse generators. New features include:
1) Redel pacing wire connection adapters; 2) Trigger modes VT and SST;
3) Sensitivity settings up to 20 mV for the Reocor S model; and
3) Programmable AV delay up to
400 ms. The device, as modified will be marketed under the trade names Reocor S and Reocor D and is indicated for: temporary pacing; temporary treatment of arrhythmias and heart block; symptomatic sinus bradycardia; Pre-, intra-, and postoperative temporary stimulation of patients undergoing cardiac surgery; termination of supraventricular tachyarrhythmias; prophylactic pacing for prevention of arrhythmias; emergency pacing; and checking pacing thresholds.
P950037/S100
5/4/12
180-Day
Lumax 700/740 and Lumax 600/640 ICD and CRT-D Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the addition of wireless telemetry and pacing vector changes.
P950037/S108
5/17/12
Real-Time
Reliaty Biotronik, Inc.
Lake Oswego, OR
97035
Approval to add a copper alloy shielding plate to be applied over the housing of a quartz crystal on the PCB and update the device labeling. The purpose for these modifications is to improve performance during RF cautery.
P960040/S257
5/3/12
Real-Time
Punctua ICD, Teligen, Energen ICD, Incepta ICD Boston Scientific Corporation
St. Paul, MN
55112
Approval for the labeling modification of the device longevity tables for the devices.
P960042/S036
5/24/12
Real-Time
SLS Spectranetics Laser Sheath Systems Spectranetics Corporation
Colorado Springs, CO
80921
Approval for a modification to the Fish Tape accessory of the device.
P960042/S037
5/16/12
Real-Time
SLS Spectranetics Laser Sheaths Spectranetics Corporation
Colorado Springs, CO
80921
Approval for qualifying the use of Loctite 7701 as a suitable replacement for the discontinued Loctite 793.
P970013/S044
5/7/12
180-Day
Microny Family of Pacemakers St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for lead failure detection and telemetry enhancements.
P970020/S070
5/25/12
180-Day
Multi-Link Coronary Stent System Abbott Vascular, Inc.
Temecula, CA
92591
Approval for a sterilization site located at Synergy Health Ireland, LTD., in Offaly, Ireland.
P970029/S019
5/25/12
180-Day
PEARL 8.0 Handpiece CryoLife
Kennesaw, GA
30144
Approval of the post-approval study protocol.
P980016/S280
5/2/12
180-Day
Medtronic Protecta™ XT VR, Protecta™ VR, Secura® VR,
Maximo II® VR ICD Systems, Model 9995 Application Software, Model SW009 Application Software Systems
Medtronic, Inc.
Mounds View, MN
55112
Approval for Medtronic Protecta™ XT VR D314VRM, Protecta™ VR D334VRM, Secura® VR
D204VRM, Maximo II® VR D264VRM ICD Systems, Model 9995 Application Software v7.3 and Model SW009 Application Software vl.0 Systems
P980022/S116
5/24/12
Real-Time
Paradigm REAL-Time System and Guardian REAL-Time System Medtronic, Inc.
Northridge, CA
91325
Approval of a change of the field effect transistor (FET), a component
of the Paradigm REAL-Time Revel Insulin Pumps (Models MMT-523, MMT-723, MMT-523K, MMT-723K), the Paradigm REAL-Time Insulin Pumps (Models MMT-522, MMT-722, MMT-
522K, MMT-722K), and the Guardian REAL-Time Monitor (Models CSS7100 and CSS7100K), which are components of the Paradigm REAL-Time and Guardian REAL-Time Systems.
P980022/S117
5/17/12
Real-Time
Medtronic MiniMed Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325
Approval for software changes to the CareLink Personal Therapy Management System for Diabetes MMT-7333, v5.8A for use with the device.
P000009/S047
5/4/12
180-Day
Lumax 700/740 and Lumax 600/640 ICD and CRT-D Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the addition of wireless telemetry and pacing vector changes.
P000053/S031
5/7/12
180-Day
AMS 800 Artificial Urinary Sphincter American Medical Systems, Inc.
Minnetonka, MN
55343
Approval for changes in the material formulation and specifications of the suture-tie connectors.
P010012/S287
5/3/12
Real-Time
Punctua CRT-D, Cognis, Energen CRT-D and Incepta CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Approval for the labeling modification of the device longevity tables for the devices.
P010013/S043
5/3/12
Real-Time
NovaSure Impedence Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA
01752
Approval for two alternative power supplies.
P010019/S028
5/11/12
180-Day
Lotrafilcon B – LFB110, O 2Optix, Air Optix Aqua, Air Optix for Astigmatism, Air Optix Aqua Multifocal CIBA VISION Corporation
Duluth, GA
30097
Approval for a manufacturing site located at CIBA VISION in Johor, Malaysia.
P010020/S017
5/7/12
180-Day
Acticon® Neosphincter American Medical Systems, Inc.
Minnetonka, MN
55343
Approval for changes in the material formulation and specifications of the suture-tie connectors.
P010023/S007
5/10/12
180-Day
MAXUM System Ototronix, LLC
St. Paul, MN
55110
Approval for a design change to the wireform coil that is used to attach the Implant Assembly to the ossicular chain.
P010047/S011
5/10/12
180-Day
NeoMend ProGEL Pleural Air Leak Sealant NeoMend, Incorporated
Irvine, CA
92618
Approval for the addition of NeoMend, Incorporated, Irvine,
California as a second source supplier for the Human Serum Albumin (HSA) Protein Cartridges
for the device.
P020047/S041
5/25/12
180-Day
Multi-Link Vision Coronary Stent System Abbott Vascular, Inc.
Temecula, CA
92591
Approval of a sterilization site located at Synergy Health Ireland, LTD., in Offaly, Ireland.
P030005/S079
5/1/12
180-Day
Invive Programer Application Software Boston Scientific Corporation
St. Paul, MN
55112
Approval for Invive Models V172, V173 Programmer 2869 Application Software Version 1.07
P030011/S011
5/16/12
180-Day
SynCardia Temporary Total Artificial Heart (TAH-t) System SynCardia Systems, Inc.
Tucson, AZ
85713
Approval for the Companion 2 Driver System.
P030025/S062
5/4/12
180-Day
TAXUS® Express 2™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) Boston Scientific Corporation
Maple Grove, MN
55311
Approval for revisions to the Directions for Use (DFU) to incorporated the latest available clinical follow-up data.
P030032/S014
5/3/12
135-Day
PREVELLE® Silk Genzyme Corporation
Cambridge, MA
02142
Approval for the addition of a new product data and laboratory information management system.
P030035/S089
5/7/12
180-Day
Frontier, Frontier II, Anthem CRT-P Devices St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for lead failure detection and telemetry enhancements.
P030054/S206
5/7/12
180-Day
Epic HF, Atlas+ HF, Quadra Assura, Unify Assura Family of CRT-Ds St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for lead failure detection and telemetry enhancements.
P030054/S212
5/10/12
180-Day
Atlas+ HF, Atlas II HF, Atlas II+ HF, Epic+, Epic HF, Epic+ HF, Epic II HF, Epic II+ HF, Promote, Promote+, Promote RF, Promote Accel, Promote Q, Promote Quadra, Unify and Unify Quadra St. Jude Medical, Inc.
Sylmar, CA
91392
Approval for a manufacturing site located at St. Jude Medical Operations Malaysia (SJM-MYPE) in Penang, Malaysia.
P040003/S011
5/1/12
Special
ExAblate MR Guided Focused Ultrasound InSightec, Inc.
Dallas, TX
75244
Approval for labeling changes including:
1) deletion of the comment “(Outcomes of 10 pregnancies are pending as of August 2008, and outcome of one pregnancy is unknown.)” and addition of deep vein thrombosis under the section entitled “Other Adverse Events.”
P040016/S083
5/9/12
135-Day
VeriFLEX Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for the use of an alternate moisture analyzer.
P040047/S018
5/17/12
180-Day
Coaptite Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for a manufacturing site located in Sturtevant, Wisconsin.
P040047/S019
5/17/12
180-Day
Coaptite Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for a manufacturing site located in Sturtevant, Wisconsin.
P040047/S021
5/17/12
135-Day
Coaptite Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval to replace the pin gauge test with a plunger contact test and to replace the manual way of measuring the luer end of the syringe barrel with a calibrated luer gauge.
P050011/S003
5/17/12
Special
Adept Adhesion Reduction Solution (4% Icodextrin) Baxter Healthcare Corporation
McGaw Park, IL
60085
Approval for changes to the Instructions for Use to clarify that exsufflation should occur prior to instilling ADEPT.
P050023/S048
5/4/12
180-Day
Lumax 700/740 and Lumax 600/640 ICD and CRT-D Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the addition of wireless telemetry and pacing vector changes.
P050027/S002
5/2/12
Real-Time
Karl Storz Photodynamic
D-Light C (PDD) System
Karl Storz Endoscopy-America, Inc.
El Segundo, CA
90245
Approval for hardware modifications to the Karl Storz D-Light C Light Source.
P050037/S031
5/30/12
135-Day
Radiesse Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for a test result evaluation procedure.
P050052/S034
5/30/12
135-Day
Radiesse Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for a test result evaluation procedure.
P060008/S083
5/9/12
135-Day
TAXUS Liberte Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for the use of an alternate moisture analyzer.
P060022/S013
5/16/12
Real-Time
Akreos Posterior Chamber Intraocular Lens (IOL) Bausch & Lomb, Incorporated
Aliso Viejo, CA
92656
Approval to add two tabs to the haptics of the Model MI60 IOL.
P070004/S001
5/29/12
180-Day
Silicone Gel Breasts Implants Sientra, Inc.
Santa Barbara, CA
93117
Approval of the post-approval study protocol.
P070004/S002
5/29/12
180-Day
Silicone Gel Breasts Implants Sientra, Inc.
Santa Barbara, CA
93117
Approval of the post-approval study protocol.
P070004/S003
5/29/12
180-Day
Silicone Gel Breasts Implants Sientra, Inc.
Santa Barbara, CA
93117
Approval of the post-approval study protocol.
P070008/S028
5/4/12
180-Day
Lumax 700/740 and Lumax 600/640 ICD and CRT-D Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the addition of wireless telemetry and pacing vector changes.
P070014/S032
5/25/12
Real-Time
LifeStent Solo Vascular Stent System Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for minor changes to the diving sheath with pull wire component of the delivery system.
P070015/S071
5/31/12
135-Day
XIENCE V Everolimus Eluting Coronary Stent System (EECSS) Abbott Vascular
Temecula, CA
92591
Approval to add an alternative compressed gas in the manufacturing of the subject device.
P070027/S032
5/10/12
180-Day
Talent Converter Stent Graft with Xcelerant Hydro Delivery System and Talent Occluder with Occluder Delivery System Medtronic Vascular
Santa Rosa, CA
95403
Approval of the post-approval study protocol.
P080012/S001
5/3/12
180-Day
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mt. Olive, NJ
07828
Approval for the post-approval study protocol.
P080012/S002
5/4/12
180-Day
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mt. Olive, NJ
07828
Approval for the post-approval study protocol.
P080012/S003
5/4/12
180-Day
Prometra Programmable Infusion Pump System Flowonix Medical, Inc.
Mt. Olive, NJ
07828
Approval for the post-approval study protocol.
P080014/S012
5/21/12
Real-Time
Cervista HPV HR Hologic, Ic.
Marlborough, MA
01752
Approval for a software revision change from Cervista HPV HR v5.4 to Cervista HPV HR v6.0.
P080015/S007
5/21/12
Real-Time
Cervista HPV 16/18 Hologic, Inc.
Marlborough, MA
01752
Approval for a software revision change from Cervista HPV 16/18 v5.4 to Cervista HPV 16/18 v6.0.
P090016/S001
5/1/12
180-Day
BELOTERO Balance Merz Aesthetics, Inc.
Franksville, WI
53126
Approval of the post-approval study protocol.
P090022/S010
5/11/12
180-Day
Softec HD Posterior Chamber Intraocular Lens (PCIOL) Lenstec Incorporated
St. Petersburg, FL
33716
Approval for a manufacturing site located in Petersburg, Florida.
P110010/S004
5/11/12
180-Day
PROMUS Element Plus Everolimus- Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval of the post-approval study protocol.
P110010/S006
5/10/12
180-Day
PROMUS Element Plus Everolimus- Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval of the post-approval study protocol.
P110019/S001
5/7/12
180-Day
XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92591
Approval for a sterilization site located at Sterigenics, UK, Limited in Derbyshire, United Kingdom.

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/S065
5/9/12
Vistakon (etafilcon A) Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Change to a new supplier of the cure lamps used during manufacturing.
P840001/S209
5/2/12
Resume II and Resume IL Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Change in the acceptance criteria of the insulated cable and the qualification of a new supplier.
P840001/S212
5/10/12
Spinal Cord Stimulation (SCS) Implantable Neurostimulators (INS) Restore
Family and Spinal Cord Stimulation (SCS) Accessories, SCS INS Itrel Family, SNS INS Synergy Family
Medtronic Neuromodulation
Minneapolis, MN
55432
Changes in the manufacturing process at Medtronic’s supplier of grommets used in various Medtronic Neuromodulation implantable devices.
P840001/S213
5/30/12
Restore Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Tighten the acceptance criteria for the titanium content of the un-insulated wire and qualify an alternate supplier of the Ethylene Tetra-fluoro-ethylene (ETFE) micro-extrusion process.
P860057/S088
5/15/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Additional sterilization and bioburden reduction process equipment.
P860057/S089
5/30/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Expansion of a cleanroom.
P870056/S049
5/30/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Expansion of a cleanroom.
P870077/S044
5/30/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Expansion of a cleanroom.
P880006/S079
5/3/12
Regency Family of Implantable Cardiac Pacemaker Devices St. Jude Medical
Sylmar, CA
91342
Implement St. Jude Medical Distribution and Labeling System (SDLS) for all SJM CRMD products.
P880086/S218
5/3/12
Integrity, Identity, Verity, Sustain, Victory, Zephyr and Accent Family of Pacemaker devices St. Jude Medical
Sylmar, CA
91342
Implement St. Jude Medical Distribution and Labeling System (SDLS) for all SJM CRMD products.
P900056/S114
5/23/12
Rotablator Rotational Angioplasty System RotaWire Guidewire with wireClip Torquer Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P910001/S054
5/2/12
ELCA Coronary Atherectomy Catheters Spectranetics Corporation
Colorado Springs, CO
80921
Modification to the ethylene oxide sterilization cycle.
P910001/S055
5/30/12
ELCA Coronary Atherectomy Catheter Spectranetics Corporation
Colorado Springs, CO
80921
Automation of lot number assignment for printing.
P910023/S294
5/3/12
ICD Family of Devices and Fortify Family of Devices St. Jude Medical
Sylmar, CA
91342
Implement St. Jude Medical Distribution and Labeling System (SDLS) for all SJM CRMD products.
P920047/S052
5/23/12
Blazer II XP Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P960009/S141
5/2/12
Activa SC Implantable Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Change the connector rework process.
P960009/S143
5/10/12
Deep Brain Stimulation (DBS) INS Activa Family,
DBS Accessories,
DBS INS Soletra Family, DBS INS Kinetra Family
Medtronic Neuromodulation
Minneapolis, MN
55432
Changes in the manufacturing process at Medtronic’s supplier of grommets used in various Medtronic Neuromodulation implantable devices.
P960009/S144
5/30/12
Activa Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Tighten the acceptance criteria for the titanium content of the un-insulated wire and qualify an alternate supplier of the Ethylene Tetra-fluoro-ethylene (ETFE) micro-extrusion process.
P960013/S072
5/3/12
Tendril, Tendril ST, Tendril STS and Optisense Family of Leads St. Jude Medical
Sylmar, CA
91342
Implement St. Jude Medical Distribution and Labeling System (SDLS) for all SJM CRMD products.
P960028/S036
5/23/12
SENSAR Soft Acrylic Posterior Chamber Intraocular Lenses (IOL), TECNIS 1-Piece Intraocular Lens,
TECNIS Multifocal 1-Piece Lens, SENSAR 1-Piece Lens, TECNIS Monofocal Acrylic Intraocular Lens,
ReZoom Multifocal Intraocular Lens, TECNIS Multifocal Lens
Abbott Medical Optics Incorporated
Santa Ana, CA
92705
Addition of a new supplier for the UV chromophore raw material.
P960030/S036
5/3/12
Isoflex, (Isoflex S, lsoflex P, Isoflex Optim) and Passive Plus Family of Pacemaker Leads St. Jude Medical
Sylmar, CA
91342
Implement St. Jude Medical Distribution and Labeling System (SDLS) for all SJM CRMD products.
P960040/S258
5/18/12
Incepta, Energen, Punctua, Teligen, Ventak Prizm HE, Vitality, Vitality DS/DS VR/EL Vitality 2 and Confient ICDs Boston Scientific Corporation
St. Paul, MN
55112
Adding a verification step to the manufacturing process to ensure that the Spot-welding equipment is set-up correctly.
P960042/S035
5/2/12
SLS Spectranetics Laser Sheaths Spectranetics Corporation
Colorado Springs, CO
80921
Modification to the ethylene oxide sterilization cycle.
P960042/S038
5/30/12
SLS Spectranetics Laser Sheaths Spectranetics Corporation
Colorado Springs, CO
80921
Automation of lot number assignment for printing.
P960043/S079
5/3/12
Prostar XL 10F Percutaneous Vascular Suture Closure System Abbott Vascular, Inc.
Redwood City, CA
94063
Alternate supplier for the coiled suture tube.
D970003/S135
5/18/12
Pulsar/Pulsar Max/ Insigna/ Altrua Brady Pulse Generators Boston Scientific Corporation
St. Paul, MN
55112
Adding a verification step to the manufacturing process to ensure that the Spot-welding equipment is set-up correctly.
P970004/S133
5/10/12
SNS Urinary INS InterStim Family Medtronic Neuromodulation
Minneapolis, MN
55432
Changes in the manufacturing process at Medtronic’s supplier of grommets used in various Medtronic Neuromodulation implantable devices.
D970012/S090
5/2/12
AMS Model Series 700® Inflatable Penile Prosthesis Product Line and AMS Ambicor® Penile Prosthesis American Medical Systems
Minnetonka, MN
55343
Change in a measurement method used during post sterile packaging operation.
P970013/S048
5/3/12
Microny Family of Implantable Pacemaker Pulse Generator St. Jude Medical
Sylmar, CA
91342
Implement St. Jude Medical Distribution and Labeling System (SDLS) for all SJM CRMD products.
P980003/S036
5/23/12
Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P980016/S348
5/4/12
Concerto II CRT-D, Consulta, Consulta DF4, Maximo II CRT-D, Maximo II M4, Protecta
CRT-D, Protecta M4, Protecta XT
CRT-D and Protecta XT M4
Medtronic, Inc.
Mounds View, MN
55112
Software upgrade to an existing test equipment.
P980016/S349
5/10/12
Maximo II, Maximo II M4, Protecta, Protecta M4, Protecta XT,
Protecta XT M4, Secura, Secura M4, Virtuoso II DR/VR ICDs
Medtronic, Inc.
Mounds View, MN
55112
Update to the vendor inspection process for flex component.
P980016/S351
5/23/12
Maximo II DF4,
Maximo II,
Protecta DF4, Protecta, Protecta XT DF4,Protecta XT, Secura DF4,
Secura andVirtuoso II
Medtronic, Inc.
Mounds View, MN
55112
Change to the die attach cure process for selected silicon-controlled rectifier components.
P980040/S040
5/23/12
SENSAR Soft Acrylic Posterior Chamber Intraocular Lenses (IOL), TECNIS 1-Piece Intraocular Lens,
TECNIS Multifocal 1-Piece Lens, SENSAR 1-Piece Lens, TECNIS Monofocal Acrylic Intraocular Lens,
ReZoom Multifocal Intraocular Lens, TECNIS Multifocal Lens
Abbott Medical Optics Incorporated
Santa Ana, CA
92705
Addition of a new supplier for the UV chromophore raw material.
P980044/S13
5/4/12
SUPARTZ® Seikagaku Corporation
Tokoyo, Japan
Replacement of controller components.
P980049/S074
5/30/12
Paradym RF VR and DR ICDs ELA Medical, Inc.
Plymouth, MN
55441
The following changes: 1) an alternate reflow oven with an updated reflow soldering profile and an alternate component carrier; 2) an update to the rework process; 3) in-sourcing of an electronic assembly; 4) clean room layout modification at Saluggia, Italy, plant, and; 5)an alternate method for a hybrid module wire bonding process.
P990080/S037
5/23/12
SENSAR Soft Acrylic Posterior Chamber Intraocular Lenses (IOL), TECNIS 1-Piece Intraocular Lens,
TECNIS Multifocal 1-Piece Lens, SENSAR 1-Piece Lens, TECNIS Monofocal Acrylic Intraocular Lens,
ReZoom Multifocal Intraocular Lens, TECNIS Multifocal Lens
Abbott Medical Optics Incorporated
Santa Ana, CA
92705
Addition of a new supplier for the UV chromophore raw material.
P000007/S031
5/30/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Expansion of a cleanroom.
P000037/S026
5/3/12
On-X Prosthetic Heart Valve On-X Technologies, Inc.
Austin, Texas
78752
Automation of the vacuum cleaning process.
P000039/S045
5/24/12
AMPLATZER Septal Occluder and Multi-Fenestrated Septal Occluder AGA Medical Corporation
Plymouth, MN
55442
Modify the statistical sampling plan for receiving inspections of components of the subject devices.
P000053/S042
5/2/12
AMS 800 Urinary
Control System
American Medical Systems
Minnetonka, MN
55343
Change in a measurement method used during post sterile packaging operation.
P000053/S043
5/9/12
AMS 800 Artificial Urinary Sphincter American Medical Systems
Minnetonka, MN
55343
Alternate mold for the balloon adapter.
P010012/S288
5/18/12
Incepta, Energen, Punctua, Cognis, Contak Renewal 3, Contak Renewal 3 HE and Livian CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Adding a verification step to the manufacturing process to ensure that the Spot-welding equipment is set-up correctly.
P010015/S159
5/2/12
Consulta CRT-P and Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
Change in the final visual inspection process.
P010019/S030
5/16/12
Lotrafilcon A and Lotrafilcon B CIBA VISION Corporation
Duluth, GA
30097
Addition of an alternate supplier for a chemical component of the finished device.
P010019/S031
5/23/12
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear CIBA VISION Corporation
Duluth, GA
30097
Use of an improved gas chromatography (GC) test method for assessing raw materials.
P010019/S032
5/22/12
Lotrafilcon B Soft Contact Lenses for Extended Wear CIBA VISION Corporation
Duluth, GA
30097
Addition of an alternate raw material supplier for Betacon Macromer used in the formulation of Lotrafilcon B soft contact lenses.
P010020/S023
5/2/12
Acticon Neosphincter American Medical Systems
Minnetonka, MN
55343
Change in a measurement method used during post sterile packaging operation.
P010029/S015
5/4/12
EUFLEXXA (1% Sodium Hyaluronate) Ferring Pharmaceuticals, Inc.
Parsippany, NJ
07064
Addition of a new filling machine.
P010031/S300
5/4/12
Maximo II ICD, Maximo II M4, Protecta ICD, Protecta M4, Protecta XT ICD, Protecta XT M4, Secura ICD, Secura M4 and Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN
55112
Software upgrade to an existing test equipment.
P010031/S301
5/10/12
Concerto II, Consulta, Consulta DF4, Maximo II, Maximo II M4,
Protecta, Protecta M4, Protecta XT M4 CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Update to the vendor inspection process for flex component.
P010031/S303
5/23/12
Concerto II, Consulta, Consulta DF4, Maximo II, Maximo II DF4, Protecta, Protecta DF4, Protecta XT and Protecta XT DF4 Medtronic, Inc.
Mounds View, MN
55112
Change to the die attach cure process for selected silicon-controlled rectifier components.
P010032/S051
5/17/12
Eon 16-Channel IPG Neurostimulation Systems St. Jude Medical
Plano, TX
75024
Welding process change for the device.
P010041/S033
5/30/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Expansion of a cleanroom.
P010047/S020
5/30/12
Progel Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618
Add an additional supplier for sterile water.
P020004/S073
5/30/12
GORE EXCLUDER AAA Endoprosthesis W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Change to the automated manufacturing and testing documentation process.
P020009/S083
5/9/12
Express and Express 2 Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Removal of a packaging check weighing step.
P020009/S084
5/23/12
Express 2 Monorail and Over-the-Wire Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P020009/S085
5/30/12
Express 2 Monorail & Over-the-Wire Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of waist length in-process inspection steps.
P020014/S037
5/17/12
Conceptus Essure System for Permanent Birth Control Conceptus, Inc.
Mountain View, CA
94041
Replace the current manual deploy and detach test fixture with an automated test fixture for lot release testing of the Essure System.
P020024/S035
5/24/12
AMPLATZER Duct Occluder AGA Medical Corporation
Plymouth, MN
55442
Modify the statistical sampling plan for receiving inspections of components of the subject devices.
P020025/S034
5/23/12
Blazer II XP Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P020036/S024
5/22/12
SMART Nitinol Stent System Cordis Corporation
Miami Lakes, FL
33014
Changes to the sealing equipment and additions to improve the visual inspection process.
P020036/S025
5/22/12
SMART and SMART Control Nitinol Stent Systems Cordis Corporation
Miami Lakes, FL
33014
Implementation of a vision system for the inspection of pouch seals.
P030005/S083
5/18/12
Contak Renewal TR CRT-Ps Boston Scientific Corporation
St. Paul, MN
55112
Adding a verification step to the manufacturing process to ensure that the Spot-welding equipment is set-up correctly.
P030006/S025
5/17/12
Prolieve Thermodilatation System Boston Scientific Corporation
Marlborough, MA
01752
Change in a thermocouple wire joint manufacturing process.
P030017/S132
5/10/12
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Use an alternative oven during the manufacture of W4 and D4 2X4 Splitters for the device.
P030017/S133
5/24/12
Precision® Spinal Cord Stimulator (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Additional verification step to be added during manufacture testing of the Remote Control device of the device.
P030024/S019
5/24/12
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator Ortho Clinical Diagnostics, Inc.
Rochester, NY
14626
Addition of a supplier for negative human plasma.
P030025/S096
5/4/12
TAXUS Express 2 Paclitaxel-Eluting Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Additional drying cycle for the coating component of the device.
P030025/S097
5/23/12
TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P030035/S096
5/3/12
Frontier, Frontier II and Anthem Family of CRT-P Devices St. Jude Medical
Sylmar, CA
91342
Implement St. Jude Medical Distribution and Labeling System (SDLS) for all SJM CRMD products.
P030047/S025
5/22/12
PRECISE Nitinol Stent System Cordis Corporation
Miami Lakes, FL
33014
Changes to the sealing equipment and additions to improve the visual inspection process.
P030054/S221
5/3/12
CRT-D Family of Devices and Unify Quadra Family of Devices St. Jude Medical
Sylmar, CA
91342
Implement St. Jude Medical Distribution and Labeling System (SDLS) for all SJM CRMD products.
P040016/S086
5/9/12
VeriFLEX (Libertè) Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Removal of a packaging check weighing step.
P040016/S087
5/23/12
VeriFLEX (Liberte) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P040016/S088
5/30/12
VeriFLEX Monorail & Over-the-Wire Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of waist length in-process inspection steps.
P040024/S058
5/23/12
Restylane Injectable Gel Medicis Pharmaceutical Corporation
Scottsdale, AZ
85256
Test laboratory for analysis of a component to be changed to an internal chemical quality control laboratory as opposed to the current contract testing laboratory.
P040024/S059
5/24/12
Restylane Injectable Gel Medicis Pharmaceutical Corporation
Scottsdale, AZ
85256
Back-up analytical laboratory for Water for Injection (WFI), Purified Water (PW) and Clean Steam.
P040027/S028
5/30/12
GORE VIATORR TIPS Endoprosthesis W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Change to the automated manufacturing and testing documentation process.
P040037/S042
5/30/12
GORE VIABAHN Endoprosthesis W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Change to the automated manufacturing and testing documentation process.
P040037/S043
5/30/12
Gore VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Addition of leak testing and drying of graft components at the Medical East manufacturing facility.
P040040/S020
5/24/12
AMPLATZER Muscular VSD Occluder AGA Medical Corporation
Plymouth, MN
55442
Modify the statistical sampling plan for receiving inspections of components of the subject devices.
P040043/S048 GORE TAG THORACIC Endoprosthesis W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Change to the automated manufacturing and testing documentation process.
P050006/S027
5/30/12
GORE HELEX Septal Occluder W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Change to the automated manufacturing and testing documentation process.
P060006/S026
5/9/12
Express SD Renal Premounted Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Removal of a packaging check weighing step.
P060006/S027
5/23/12
Express SD Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P060006/S028
5/30/12
Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of waist length in-process inspection steps.
P060008/S087
5/4/12
TAXUS Liberte Paclitaxel-Eluting Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Additional drying cycle for the coating component of the device.
P060008/S088
5/23/12
TAXUS Liberte Paclitaxel-Eluting Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P060027/S047
5/30/12
Paradym RF CRT-D ELA Medical, Inc.
Plymouth, MN
55441
The following changes: 1) an alternate reflow oven with an updated reflow soldering profile and an alternate component carrier; 2) an update to the rework process; 3) in-sourcing of an electronic assembly; 4) clean room layout modification at Saluggia, Italy, plant, and; 5)an alternate method for a hybrid module wire bonding process.
P060040/S017
5/17/12
HeartMate II Ventricular Assist System Thoratec Corporation
Pleasanton, CA
94588
Change to the cored solder wire formulation.
P060040/S020
5/31/12
Thoratec HeartMate II LVAS Thoratec Corporation
Pleasanton, CA
94588
Changes to the supplier who manufactures the HeartMate II LVAS batteries.
P080010/S008
5/23/12
SENSAR Soft Acrylic Posterior Chamber Intraocular Lenses (IOL), TECNIS 1-Piece Intraocular Lens,
TECNIS Multifocal 1-Piece Lens, SENSAR 1-Piece Lens, TECNIS Monofocal Acrylic Intraocular Lens,
ReZoom Multifocal Intraocular Lens, TECNIS Multifocal Lens
Abbott Medical Optics Incorporated
Santa Ana, CA
92705
Addition of a new supplier for the UV chromophore raw material.
P080011/S011
5/11/12
Biofinity (comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Revalidation of Biofinity Manufacturing Line #4 with the following manufacturing changes: 1) an increase in temperature of the barrel heater on the injection molding machine; and 2) a consolidation change in the design of the fill and close module.
P080020/S001
5/4/12
Gel-One® Seikagaku Corporation
Tokoyo, Japan
Replacement of controller components.
P080025/S030
5/10/12
SNS Bowel INS InterStim Family Medtronic Neuromodulation
Minneapolis, MN
55432
Changes in the manufacturing process at Medtronic’s supplier of grommets used in various Medtronic Neuromodulation implantable devices.
P090003/S012
5/9/12
Express LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Addition of an in-process inspection for balloon manufacturing.
P100014/S006
5/4/12
Solesta Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC
27615
Additional laboratory for analytical testing
P100021/S016
5/3/12
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Supplier process transfer for stent and stent ring components.
P100023/S041
5/4/12
ION Paclitaxel-Eluting Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Additional drying cycle for the coating component of the device.
P100023/S042
5/23/12
ION Paclitaxel-Eluting Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Upgrades to sterilization equipment.
P100023/S043
5/30/12
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of waist length in-process inspection steps.
P100041/S009
5/9/12
Edwards Sapien Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Alternate receiving inspection site.
P100041/S010
5/30/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Expansion of a cleanroom.
P110010/S014
5/30/12
PROMUS Element Plus Everolimus-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of waist length in-process inspection steps.
P110013/S003
5/24/12
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular Inc.
Santa Rosa, CA
95403
Change to the sampling plan for routine end-product bacterial endotoxin testing.

Summary of PMA Originals & Supplements Approved
Originals: 0                                                                 
Supplements: 76                                                                    

Summary of PMA Originals Under Review
Total Under Review: 66                                                        
Total Active: 28                                                                     
Total On Hold: 38                                                      
Number Greater Than 180 Days: 1                            

Summary of PMA Supplements Under Review
Total Under Review: 542                                                      
Total Active: 366                                           
Total On Hold: 176                                                    
Number Greater Than 180 Days: 6                            

Summary of All PMA Submissions Received
Originals: 2                                                                 
Supplements: 72                                                                     

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 76                                                      
Number of Denials: 0                                                 
Average Days Fr Receipt to Decision (Total Time): 224.4      
FDA Time: 138.3 Days      MFR Time: 86.1 Days