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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

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