Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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. Information about the PDF Reader is available.
PMA Original Approvals
|
7/28/06 |
Adept® (4% Icodextrin) Adhesion Reduction Solution |
Innovata PLC Northborough , MA 01532 |
Approval for the Adept® (4% Icodextrin) Adhesion Reduction Solution. The device is indicated for use intraperiotoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis. |
|
7/10/06 |
Fuji Computed Radiography Mammography Suite (FCRMS) |
Fujifilm Medical Systems USA, Inc. Stamford , CT 06902 |
Approval for the Fuji Computed Radiography Mammography Suite (FCRMS). The FCRMS is a software device that, in conjunction with a specified Fuji Computed Radiography system, forms the Fuji Computed Radiography for mammography (FCRm) device. FCRm with a dedicated mammographic x-ray machine generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic (SFM) systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation. |
PMA Supplemental Approvals
P820018/S075 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P820018/S077 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P830045/S096 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P830045/S100 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P840001/S092 7/7/06 180-Day |
Restore ADVANCED™ and Prime ADVANCED™ Neurostimulation Systems |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Restore ADVANCED™ and Prime ADVANCED™ Neurostimulation Systems. The devices are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: 1) Failed Back Syndrome or Low Back Syndrome or Failed Back; 2) Radicular Pain Syndrome or radiculopathies resulting in pain secondary to Failed Back Syndrome; 3) Post Laminectomy Pain; 4) Unsuccessful Disk Surgery; 5) Degenerative Disk Disease (DDD)/Herniated Disk pain refractory to conservative and surgical interventions; 6) Peripheral Causalgia; 7) Epidural Fibrosis; 8) Arachnoiditis or Lumbar Adhesive Arachnoiditis; 9) Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and 10) Multiple Back Surgeries. |
P840001/S093 7/18/06 Real-Time |
Restore ADVANCED, Prime ADVANCED, Restore PRIME, Restore, Synergy Plus, Synergy Compact+, Synergy , Synergy Versitrel, Itrel 3 and Itrel II |
Medtronic Neurological Minneapolis , MN 55432 |
Approval for changes to the platform software on the Model 8840 N’Vision Programming System. |
P850022/S016 7/27/06 180-Day |
OrthoPak2 Bone Growth Stimulator System |
EBI, L.P. Parsippany , NJ 07054 |
Approval for the following device modifications: 1) The stimulator has been modified to include: a) A new user interface (similar to P850022/S015). The user interface includes an alarm button, yellow LED, and a LCD display to indicate treating status; b) An audible and visible self-checking alarm mechanism with additional malfunction source indicators (same as P850022/S015). The audible alarm mechanism can be disabled using the alarm button; c) A new main PCB circuit board (same as P850022/S015); d) Software C program language (same as P850022/S015); e) An elapsed time accumulator/patient monitoring function (similar to P850022/S015). After 270 days of elapsed treatment time or 400 days of total activation time the 7unit will no longer generate a signal. 2) The power source has been modified from a disposable battery to a rechargeable NiMH “AA” battery. The device includes two rechargeable batteries and a single cell battery charger. The device, as modified, will be marketed under the trade name OrthoPak2 Bone Growth Stimulator System and is indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, where the width of the nonunion defect is less than one-half the width of the bone to be treated. A nonunion is considered to be established when the fracture site shows no visible progressive signs of healing. |
P860003/S044 7/14/06 Special |
UVAR® XTS™ Photopheresis System |
Therakos, Inc. Exton , PA 19341 |
Approval for a labeling change to include information on extracorporeal blood volume management and the importance of testing patients’ hematocrit values. |
P860004/S083 7/5/06 Real-Time |
SynchroMed and IsoMed Implantable Infusion Pumps: Medtronic Model 8840 N’Vision Programming System |
Medtronic Neurological Minneapolis , MN 55432 |
Approval for changes to the platform software on the Model 8840 N’Vision Programming System |
P880006/S039 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P880006/S043 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P880038/S037 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P880047/S010 7/3/06 180-Day |
INTERCEED (TC7) Absorbable Adhesion Barrier |
Ethicon, Inc. Somerville , NJ 08876 |
Approval for a change to the yarn used in the device. |
P880081/S032 7/20/06 Real-Time |
TECNIS™ CL Foldable Silicone Posterior Chamber Intraocular Lens (Model Z9002) |
Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Approval for a change in haptic material, addition of the OptiEdge and of a modified prolate anterior optic surface to the SI20NB lens and labeling claims for reduced postoperative spherical aberrations and improved night-driving simulator performance. The device, as modified, will be marketed under the trade name TECNIS™ CL Foldable Silicone Posterior Chamber Intraocular Lens (Model Z9002) and is indicated for primary implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular extraction or phacoelmulsifica-tion. These devices are intended to be placed in the capsular bag. |
P880086/S116 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P880086/S122 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P890003/S105 7/12/06 Real-Time |
EnTrust ICD and the CardioSight Reader |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for adding support for the Concerto Model C154DWK and Virtuoso Models D154AWG/ D154VWC to the Model 2020A CardioSight Readers and the Correction of an anomaly in the Model 2491 DDMA affecting the Entrust family of ICDs. |
P900022/S007 7/26/06 Real-Time |
Elaview 1.34 UGI programming software for Defender II model 9201; Defender IV model 612; Alto models 614 and 615; Alto 2 models 624 and 625; and Ovatio models 6550 and 6250 |
ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the Elaview 1.34 UGI programming software. |
P900023/S044 7/7/06 Real-Time |
42 Fr. Ventricular Cannula with Integrated Swing Cuff |
Abiomed, Inc. Danvers , MA 01923 |
Approval for design changes to integrate the previously approved 42 Fr. Ventricular/Atrial Cannula and previously approved sewing cuff accessory. The device, as modified, will be marketed under the trade name 42 Fr. Ventricular Cannula with Integrated Sewing Cuff and is indicated for use with the BVS 5000 Biventricular Support System and with the AB5000 Circulatory Support System. |
P900060/S033 7/21/06 180-Day |
CarboMedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis and Carbo-Seal Valsalva Ascending Aortic Prosthesis |
CarboMedics, Inc. Austin , TX 78752 |
Approval for a manufacturing site located at the Sorin Biomedica Cardio, S.r.l. facility in Saluggia, Italy to manufacture pyrolytic carbon components for the CarboMedics Prosthetic Heart Valve, Carbo-Seal Ascending Aortic Prosthesis and Carbo-Seal Valsalva Ascending Aortic Prosthesis devices. |
P900061/S066 7/12/06 Special |
Medtronic PCD Tachyarrhythmia Control System |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of the prescription label inadvertently omitted from the manuals for the Medtronic® Model 5719 Active Can Emulator® (ACE) and the Model 5460 ACE Header. |
P900070/S030 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P900070/S034 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P910023/S102 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P910023/S111 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P910023/S112 7/11/06 Real-Time |
Cadence Model V-100 |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the St. Jude Medical Atlas II/II+ VR/DR/HF Implantable Cardioverter Defibrillator System. The Atlas II/II+ devices are supported by the Model 3510 Programmer with Model 3307 v6.1 (or higher) programmer software or the Merlin Patient Care System Model 3650 with Model 3330 v3.0 (or higher) programmer software. |
P910061/S013 7/20/06 Real-Time |
Advanced Optics Violet-Shield Model LI61AOV Intraocular Lens |
Bausch & Lomb San Dimas , CA 91773 |
Approval for labeling changes for the Advanced Optics Violet-Shield Model LI61AOV Intraocular Lens. The device, as modified, will be marketed under the trade name Advanced Optics Violet-Shield Model LI61AOV Intraocular Lens and is indicated to be used for primary implantation for the correction of aphakia in adult patients where a cataractous lens has been removed by extracapsular cataract extraction methods. The lens is intended for placement in the ciliary sulcus or capsular bag. |
P940031/S050 7/28/06 135-Day |
DISCOVERY, MERIDIAN |
Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for updating the gold bumps incoming inspection. |
P950022/S030 7/7/06 Real-Time |
Riata ST Optim™ Lead Models 7020, 7021, 7022, 7030, 7031, 7070 and 7071 |
St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval to place an overlay over the silicone lead body of the Riata ST leads to create the new Riata ST Optim™ Lead Models 7020, 7021, 7022, 7030, 7031, 7070 and 7071 and are indicated for use with compatible pulse generators. |
P950029/S026 7/26/06 Real-Time |
Elaview 1.34 UGI programming software for Chorus RM model 7034; Opus RM model 4534; Brio models 112, 212, 220, 222; Talent 113, 213, 223; Opus G 4621, 4624; Talent II models 133, 233; Symphony 2250, 2550; and ELA Rhapsody 2530, 2510, 2210 |
ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the Elaview 1.34 UGI programming software. |
P950037/S045 7/26/06 Real-Time |
Programmer Software Modification (601.U and A-K00.8.U) for use in Biotronik Pacemakers and Implantable Cardioverter Defibrillators |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for programmer software modifications (601.U and A-K00.8.U) for use in Biotronik Pacemakers and Implantable Cardioverter Defibrillators. The modifications included adding the 1-Opt feature, expanding programmer capabilities, improving printing and data import/export capabilities, enhancing communication and memory, updating programmability and RAM and correcting software anomalies. The software is for use with EPR 1000 PLUS programming system, TMS 1000 PLUS programming system and ICS 3000 Implant Control system. |
P960009/S039 7/27/06 Real-Time |
Medtronic Activa® Parkinson’s Control Therapy: Medtronic Model 8840 N’Vision Programming System |
Medtronic Neurological Minneapolis , MN 55432 |
Approval for changes to the platform software on the Model 8840 N’Vision Programming System. |
P960040/S110 7/28/06 135-Day |
PRIZM, VITALITY |
Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for updating the gold bumps incoming inspection. |
P960058/S054 7/28/06 180-Day |
Harmony HiResolution Bionic Ear System |
Advanced Bionics Corporation Sylmar , CA 91342 |
Approval for a cochlear implant system name change from “HiResolution Bionic Ear System” to “Harmony HiResolution Bionic Ear System”. The device, as modified, will be marketed under the trade name Harmony HiResolution Bionic Ear System and is indicated for adults and the pediatric population aged 12 months through 17 years, 11 months of age. |
D970003/S062 7/28/06 135-Day |
DISCOVERY, PULSAR MAX, INSIGNIA, NEXUS, INTELIS |
Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for updating the gold bumps incoming inspection. |
P970013/S006 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P970013/S010 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P970020/S047 7/13/06 Special |
MULTI-LINK® Coronary Stent System |
Abbott Vascular, Inc. Temecula , CA 92591 |
Approval for modifications for the IFUs to include additional information regarding the material components of the stents. |
P970043/S025 7/5/06 180-Day |
LADARVision® 4000 Excimer Laser System and the LADAR™ 6000 Excimer Laser System |
Alcon Laboratories, Inc. Orlando, FL 32826 |
Approval for an expansion of the allowable range for the physician adjustment of defocus offset parameter for the wavefront-guided myopia and myopic astigmatism indications from ±0.75 D to up to 1.00 D increase (more myopic treatment) and up to 2.50 D decrease (less myopic treatment). |
P980016/S075 7/26/06 Real-Time |
Marquis DR/VR Models 7274, 7230B, 7230CX, 7230E; InSync Marquis Model 7277; InSync II Marquis Model 7289; InSync III Marquis Model 7279; and InSync II Protect Model 7295 |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for a modification to the high voltage capacitor liner user in the referenced defibrillators. |
P980016/S076 7/12/06 Real-Time |
Virtuoso ICD |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for adding support for the Concerto Model C154DWK and Virtuoso Models D154AWG/ D154VWC to the Model 2020A CardioSight Readers and the Correction of an anomaly in the Model 2491 DDMA affecting the Entrust family of ICDs. |
P980023/S023 7/11/06 Real-Time |
Linox TD Implantable Cardioverter Defibrillator Leas |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for a lead based on the Kentrox SL and Linox SD ICD leads with 0.11 mm filaments in the lead tip conductor. The device, as modified, will be marketed under the trade name Linox TD Implantable Cardioverter Defibrillator Lead and is indicated for use in conjunction with a Biotronik ICD. Currently, data is not available regarding the use of these lead systems with ICDs of other manufacturers. Use of other ICDs may adversely affect sensing and/or therapy delivery. |
P980023/S024 7/26/06 Real-Time |
Programmer Software Modification (601.U and A-K00.8.U) for use in Biotronik Pacemakers and Implantable Cardioverter Defibrillators |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for programmer software modifications (601.U and A-K00.8.U) for use in Biotronik Pacemakers and Implantable Cardioverter Defibrillators. The modifications included adding the 1-Opt feature, expanding programmer capabilities, improving printing and data import/export capabilities, enhancing communication and memory, updating programmability and RAM and correcting software anomalies. The software is for use with EPR 1000 PLUS programming system, TMS 1000 PLUS programming system and ICS 3000 Implant Control system. |
P980035/S043 7/17/06 180-Day |
Adapta, Versa and Sensia Families of Implantable Pulse Generators |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for Adapta, Versa and Sensia Families of Implantable Pulse Generators with software SW003 Version 1.3. |
P980037/S016 7/11/06 180-Day |
AngioJet® XMI and XMI-RX Catheters |
Possis Medical, Inc. Minneapolis , MN 55433 |
Approval for labeling changes to the IFU for the AngioJet XMI and AngioJet XMI-RX Catheters for use in the coronary vasculature. |
P980049/S023 7/26/06 Real-Time |
Elaview 1.34 UGI programming software for Chorus models 6001, 6003, 6004, 6033, and 6034 |
ELA Medical, Inc. Plymouth , MN 55441 |
Approval for the Elaview 1.34 UGI programming software. |
P000009/S019 7/26/06 Real-Time |
Programmer Software Modification (601.U and A-K00.8.U) for use in Biotronik Pacemakers and Implantable Cardioverter Defibrillators |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for programmer software modifications (601.U and A-K00.8.U) for use in Biotronik Pacemakers and Implantable Cardioverter Defibrillators. The modifications included adding the 1-Opt feature, expanding programmer capabilities, improving printing and data import/export capabilities, enhancing communication and memory, updating programmability and RAM and correcting software anomalies. The software is for use with EPR 1000 PLUS programming system, TMS 1000 PLUS programming system and ICS 3000 Implant Control system. |
P000028/S008 7/25/06 180-Day |
Affinity® Anterior Cervical Cage System |
Medtronic Sofamor Danek Memphis , TN 38132 |
Approval for changes to the device labeling to incorporate data collected from the post market study of the device. |
P000029/S018 7/27/06 Special |
Deflux® Injectable Gel |
Q-MED Scandinavia, Inc. Princeton , NJ 08540 |
Approval for labeling changes in the Deflux® Package Insert. |
P000032/S013 7/3/06 180-Day |
Her Option™ Cryoablation therapy System |
American Medical Systems, Inc. Minnetonka , MN 55343 |
Approval for: 1) updates to the software, i.e., in-ice detection; 2) improvement in the locking tabs; and 3) labeling changes. |
P000032/S019 7/28/06 135-Day |
Her Option™ Cryoablation Therapy System |
American Medical Systems Minnetonka , MN 55343 |
Approval for an addition of a test fixture to automate the inspection of the Her Option Cryoablation disposable probe. |
P000041/S003 7/27/06 180-Day |
Rapid Screen RS-2000, RS-2000D and RS-Digital |
Riverain Medical Group Miamisburg , OH 45342 |
Approval for a manufacturing site located at Riverain Medical Group, Miamisburg, Ohio. |
P000044/S013 7/14/06 Real-Time |
VITROS Immunodiagnostic HBsAg Reagent Pack and HBsAg Confirmatory Assay |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Approval for removal of a warning regarding assay performance characteristics with neonates. |
P000057/S003 7/17/06 180-Day |
Ascension MCP |
Ascension Orthopedics, Inc. Austin , TX 78754 |
Approval to add a size 05 implant to the product line. |
P010012/S110 7/28/06 135-Day |
CONTAK CD, EASYTRAK |
Guidant Corporation Cardiac Rhythm Management St. Paul , MN 55112 |
Approval for updating the gold bumps incoming inspection. |
P010012/S133 7/17/06 Real-Time |
Contak Renewal and Contak Renewal 3 |
Guidant Corporation 55112 |
Approval for labeling changes to the Contak Renewal and Contak Renewal 3 to ensure consistency with the approved labeling for the Contak Renewal 3RF. |
P010014/S009 7/18/06 Special |
Oxford® Meniscal Unicompartmental Knee System |
Biomet, Inc. Warsaw , IN 46581 |
Approval for changes to the process specifications for the 9-Stage Kerry Cleaning plant used in the ultrasonic cleaning of the Oxford Meniscal Unicompartmental Knee System metallic components (femoral and tibial). The changes require detailed monitoring of the ultrasonic equipment to ensure the adequacy of its output. |
P010031/S042 7/26/06 Real-Time |
Marquis DR/VR Models 7274, 7230B, 7230CX, 7230E; InSync Marquis Model 7277; InSync II Marquis Model 7289; InSync III Marquis Model 7279; and InSync II Protect Model 7295 |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for a modification to the high voltage capacitor liner user in the referenced defibrillators. |
P010031/S044 7/12/06 Real-Time |
Concerto CRT-ICD |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for adding support for the Concerto Model C154DWK and Virtuoso Models D154AWG/ D154VWC to the Model 2020A CardioSight Readers and the Correction of an anomaly in the Model 2491 DDMA affecting the Entrust family of ICDs. |
P010033/S009 7/25/06 180-Day |
QuantiFERON-TB Gold |
Cellestis, Inc. Valencia , CA 91355 |
Approval for a contract manufacturing site located at Scantibodies Laboratory, Inc., Santee, California. |
P010054/S005 7/28/06 Special |
Elecsys Anti-HBs Immunoassay Test System |
Roche Diagnostic Corp. Indianapolis , IN 46250 |
Approval for changes in the quality control (QC) testing procedure of raw materials for Calibrators and Controls. |
P020030/S003 7/12/06 Real-Time |
Stelix II Easy Turn Models BRF24D, BRF25D, and BRF26D |
ELA Medical, Inc. Plymouth , MN 55441 |
Approval for modifications to the helix mechanism, addition of radiopaque markers, and modifications to the device inspection procedures. The device, as modified, will be marketed under the trade name Stelix II Easy Turn Models BRF24D, BRF25D, and BRF26D and are designed to be used with an implantable pacemaker for pacing and sensing of the heart. |
P020045/S015 7/5/06 135-Day |
Freezor® Cardiac CryoAblation Catheters; Freezor® Xtra and Freezor® MAX Surgical CryoAblation Catheters; and CCT.2 CryoConsole System |
Applied Physics Brookline , MA 02445 |
Approval for changes in cleaning methods used to remove manufacturing materials. |
P020047/S006 7/13/06 Special |
MULTI-LINK VISION® Coronary Stent System |
Abbott Vascular, Inc. Temecula , CA 92591 |
Approval for modifications for the IFUs to include additional information regarding the material components of the stents. |
|
7/26/06 Panel |
WaveLight Allegretto Wave™ Excimer Laser System |
SurgiVision® Regulatory Consultants, Inc. North Reading , MA 01864 |
Approval for the WaveLight Allegretto Wave™ Excimer Laser System used in conjunction with the WaveLight Allegro Analyzer. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. |
P030035/S009 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P030035/S016 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P030054/S023 7/28/06 180-Day |
Selected Families and Models of the ICD’s; EPIC II/EPIC II Implantable Cardioverter Defibrillator; Frontier and Frontier II CRT-P Devices; Various families of Pacemakers; Aurora/Quandra, Freflex, Simplex, Meta and Tempo Pacemakers; Regency, Sensolog, and Dialog Pacemakers; Paragon, Phoenix, Multilog and Sensorithm Pacemakers; Microny Pacemakers |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the modifications to the programmer software, Model 3307 v6.1.1c and Model 3330 v4.1.1, to include the QuickOpt Timing Cycle feature. |
P030054/S030 7/11/06 Real-Time |
All Pacemakers and Implantable Defibrillator Models |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 v4.0 Software for use on the model 3650 Merlin Patient Care System and the Model 3307 v6.1.1m Software for use on the Model 3510 Programmer. |
P030054/S031 7/11/06 Real-Time |
EPIC HF V-338 |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the St. Jude Medical Atlas II/II+ VR/DR/HF Implantable Cardioverter Defibrillator System. The Atlas II/II+ devices are supported by the Model 3510 Programmer with Model 3307 v6.1 (or higher) programmer software or the Merlin Patient Care System Model 3650 with Model 3330 v3.0 (or higher) programmer software. |
P040012/S009 7/18/06 135-Day |
RX Acculink™ Carotid Stent System |
Abbott Vascular, Vascular Solutions Santa Clara , CA 95054 |
Approval for a modification to a manufacturing process to improve wicking of glue between the hypotube and the inner member and a modification to the Lot History Record Bill of Materials to add a new block for documenting the new process. |
P040012/S016 7/11/06 Special |
Acculink™ and RX Acculink™ Carotid Stent System |
Abbott Vascular, Vascular Solutions Santa Clara , CA 95054 |
Approval for changes to the labeling printing and inspection procedures. |
P040012/S017 7/14/06 Special |
Acculink™ and RX Acculink™ Carotid Stent System |
Abbott Vascular, Vascular Solutions Santa Clara , CA 95054 |
Approval for a tightening of the sampling level for partial stent deployment. |
P040013/S004 |
GEM 21S (Growth-factor Enhanced Matrix) |
Biomimetic Therapeutics, Inc. |
Approval for a new ELISA PDGF-BB Identity Test. |
P040042/S003 7/20/06 Real-Time |
Therapy Dual 8 Catheter and IBI-1500T6 Cardiac Ablation Generator |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for a minor design change which added a volume control to the audible output device to permit the user to vary the volume of the continuous beeping sound made during radiofrequency delivery of power. |
30-Day Notices (135 Day Supplement was not required)
P840068/S044 7/26/06 |
DELTA® Pacemaker System |
Guidant Corporation, Cardiac Rhythm Management St. Paul , MN 55112 |
Changes to the software load process for the Model 3120 ZOOM Latitude Programmer used with the devices. |
P860057/S035 7/18/06 |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis |
Edwards Lifesciences, LLC Irvine , CA 92614 |
Change from a manual to an automated sewing of the anchor seamline stitch. |
P910023/S113 7/31/06 |
ICDs/CRT-Ds |
St. Jude Medical Cardiac Rhythm Management Div. Sunnyvale , CA 94086 |
Change from a manual to an automated masking process. |
P910077/S063 7/26/06 |
Model 3120 ZOOM Latitude Programmer |
Guidant Corporation, Cardiac Rhythm Management St. Paul , MN 55112 |
Changes to the software load process for the Model 3120 ZOOM Latitude Programmer used with the devices. |
P940031/S057 7/26/06 |
VIGOR® DR/SR Pacemaker System |
Guidant Corporation, Cardiac Rhythm Management St. Paul , MN 55112 |
Changes to the software load process for the Model 3120 ZOOM Latitude Programmer used with the devices. |
P960013/S021 7/19/06 |
Tendril Family of Leads |
St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Alternate automated test process during the inspection of Tendril family of leads. |
P960040/S129 7/19/06 |
VENTAK AV/VR Devices |
Guidant Corporation Saint Paul , MN 55112 |
Modification to a tool used during the hybrid folding process in electronic assembly. |
P960040/S130 7/26/06 |
VENTAK AV AICD System |
Guidant Corporation, Cardiac Rhythm Management St. Paul , MN 55112 |
Changes to the software load process for the Model 3120 ZOOM Latitude Programmer used with the devices. |
D970003/S077 7/26/06 |
PULSAR™/ PULSAR MAX™ Pacemaker System |
Guidant Corporation, Cardiac Rhythm Management St. Paul , MN 55112 |
Changes to the software load process for the Model 3120 ZOOM Latitude Programmer used with the devices. |
|
7/18/06 |
AMPLATZER® Septal Occluder |
AGA Medical Corporation Golden Valley , MN 55427 |
Change to the cleaning process for the device. |
P010003/S008 7/26/06 |
BioGlue Surgical Adhesive |
CryoLife, Inc. Kennesaw , GA 30144 |
Change of BSA suppliers. |
P010012/S134 7/26/06 |
CONTAK CD/ EASYTRAK CRT-D System |
Guidant Corporation, Cardiac Rhythm Management St. Paul , MN 55112 |
Changes to the software load process for the Model 3120 ZOOM Latitude Programmer used with the devices. |
|
7/18/06 |
AMPLATZER® Duct Occluder |
AGA Medical Corporation Golden Valley , MN 55427 |
Change to the cleaning process for the device. |
P020036/S003 7/19/06 |
S.M.A.R.T.® Nitinol Stent System and the S.M.A.R.T.® CONTROL™ Nitinol Stent System |
Cordis Corporation Warren , NJ 07059 |
Change to the bio-inert filler ingredient that is primarily used as a thickening agent for the UV adhesive. |
P020036/S004 7/19/06 |
S.M.A.R.T.® Nitinol Stent System and the S.M.A.R.T.® CONTROL™ Nitinol Stent System |
Cordis Corporation Warren , NJ 07059 |
Change to the coining and riveting process of the tantalum microsmarkers to the S.M.A.R.T. CONTROL Stent. |
|
7/26/06 |
CONTAK RENEWAL TR CRT-P System |
Guidant Corporation, Cardiac Rhythm Management St. Paul , MN 55112 |
Changes to the software load process for the Model 3120 ZOOM Latitude Programmer used with the devices. |
P030054/S032 7/31/06 |
ICDs/CRT-Ds |
St. Jude Medical Cardiac Rhythm Management Div. Sunnyvale , CA 94086 |
Change from a manual to an automated masking process. |
P040038/S002 7/18/06 |
Xact® Carotid Stent System |
Abbott Vascular Devices Redwood City , CA 94063 |
Changes regarding adhesive bonding, abrasion process change, stent process change, and changes to final inspection. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 73
Summary of PMA Originals Under Review
Total Under Review: 94
Total Active: 41
Total On Hold: 53
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 398
Total Active: 194
Total On Hold: 204
Number Greater Than 180 Days: 12
Summary of All PMA Submissions Received
Originals: 0
Supplements: 87
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 73
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 91.8
FDA Time: 78.6 Days MFR Time: 13.3 Days
Updated September 17, 2007
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