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Medical Devices
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May 2009 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P050050 5/27/09 |
Scandinavian Total Ankle Replacement System (STAR Ankle) | Small Bone Innovations, Inc. Morrisville, PA 19067 |
Approval for the STAR Ankle. The device is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. |
| P060023 5/12/09 |
BRYAN® Cervical Disc | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for the BRYAN® Cervical Disc. The device is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy. The BRYAN® device is implanted via an open anterior approach. Intractable radiculopathy and/or myelopathy is defined as any combination of the following: disc herniation with radiculopathy. spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy resulting in impaired function and at least one clinical neurological sign associated with the cervical level to be treated, and necessitating surgery as demonstrated using computed tomography (CT), myelography and CT, and/or magnetic resonance imaging (MR1). Patients receiving the BRYAN® Cervical Disc should have failed at least six weeks of non-operative treatment prior to implantation of the BRYAN® Cervical Disc. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N16895/S091 5/5/09 Real-Time |
Bausch & Lomb Soflens (polymacon) Contact Lens | Bausch & Lomb, Inc. Rochester, NY 14609 |
Approval for the use of an alternate resin Sunoco D-115A to form the blister package container for the device. |
| P820003/S091 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P830055/S109 5/18/09 Real-Time |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for the addition of the Sigma CR150 Femoral Components as compatible components with the MBT Tibial Trays and the Curved RP Tibial Inserts. |
| P840001/S134 5/20/09 135-Day |
30 cm Specify 5-6-5 Lead | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for manufacturing changes to the Specify 5-6-5 Lead, Model 39565-30. |
| P850051/S070 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P860057/S042 5/7/09 180-Day |
Carpentier-Edwards® Perimount® Magna Ease™ Pericardial Aortic Bioprostheses | Edwards Lifesciences, LLC Irvine, CA 92714 |
Approval for design and manufacturing modifications to the Carpentier-Edwards® Perimount ® Magna Ease™ Pericardial Aortic Bioprostheses, Model 3000TFX, including changes to the Elgiloy® band and the polyester band. The device, as modified, will be marketed under the trade name Carpentier -Edwards® Perimount ® Magna Ease™ Pericardial Aortic Bioprostheses. Model 3300TFX, and is indicated for patients who require replacement of their native or prosthetic aortic valve. |
| P890003/S154 5/1/09 180-Day |
CareLink Monitor Model 2490C | Medtronic, Inc. Mounds View, MN 55112 |
Approval for design and manufacturing process modifications to the existing Medtronic CareLink® Monitor Model 2490C to produce the 2490C low cost monitor. |
| P890003/S168 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P900061/S083 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P910007/S017 5/29/09 180-Day |
Architect® Total PSA Assay | Abbott Laboratories Abbott Park, IL 60064 |
Approval for migration of the Architect® Total PSA Assay to a new Architect® i System family member, the Architect® i 1000 SR. |
| P910023/S200 5/7/09 180-Day |
SJM Model 3510 Programmer and Merlin Model 3650 Programmer | St. Jude Medical Sylmar, CA 91342 |
Approval of the post-approval study protocol. |
| P910023/S206 5/7/09 Real-Time |
Cadence Family of ICDs | St. Jude Medical Sylmar, CA 91342 |
Approval for: 1) Replacing the existing hand solder interconnections between subassemblies with plug/receptacle connectors, epoxy, direct solder or laser welding. 2) Using an organic substrate for the hybrid module. 3) Reconfiguring discrete surface mount magnetic components (e.g. HV converter board assembly, sensor support assembly) to integrate them into the hybrid. |
| P920015/S054 5/14/09 180-Day |
IS-1 Connect Port Pin Plug Kit | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Center (MPROC) in Villalba, Puerto Rico as an alternate manufacturer for the device. |
| P930022/S009 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P950022/S056 5/7/09 180-Day |
Riata St Optim Lead and Durata Lead | St. Jude Medical Sylmar, CA 91342 |
Approval of the post-approval study protocol. |
| P950032/S051 5/19/09 Real-Time |
Apligraf (Graftskin) | Organogenesis, Inc. Canton, MA 02021 |
Approval for a new cell strain, HEP 016, for introduction into production of Apligraf. |
| P950037/S068 5/12/09 180-Day |
Philos, Cyclos Families of Pulse Generators | Biotronik, Inc. Lake, Oswego, OR 97035 |
Approval for modification of product labeling for devices that utilize home monitoring. Specifically, supplements requested approval for the replacement of existing precautions and the following marketing statements: 1) Biotronik Home Monitoring information may be used as a replacement for device interrogation during in-office follow-up visits. 2) A strategy of care using Biotronik Home Monitoring with office visits when needed - has been shown to extend the lime between routine, scheduled in-office Follow-ups of Biotronik implantable devices in many patients. Home Monitoring data is helpful in determining the need for additional in-office follow-up. 3) Biotronik Home Monitoring patients -who are followed remotely with office visits when needed - have been shown to have similar numbers of strokes, invasive procedures and deaths as patients followed with conventional in-office follow-ups. 4) Biotronik Home Monitoring provides early detection of arrhythmias. 5) Biotronik Home Monitoring provides early detection of silent, asymptomatic arrhythmias. 6) Automatic early detection of arrhythmias and device system anomalies by Biotronik Home Monitoring allows for earlier intervention than conventional in-office follow-ups. 7) Biotronik Home Monitoring allows for improved access to patient device data compared to conventional in-office follow-ups since device interrogation is automatically scheduled at regular intervals. |
| P960009/S065 5/7/09 Special |
Activa Deep Brain Stimulation (DBS) | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for labeling changes for the Activa DBS lead models 3387, 3389, 3387(S), and 3389(S). |
| P960013/S044 5/21/09 135-Day |
Tendril® Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the use of an additional supplier for the crimp core component. |
| P960013/S046 5/26/09 Real-Time |
Tendril STS Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for distal tip changes to the Tendril ST Model 1888 lead family. The device, as modified, will be marketed under the trade name Tendril STS Model 2088TC, and are transvenous steroid eluting leads indicated for use in the right atrium or right ventricle, in combination with a compatible pulse generator. |
| P960040/S193 5/26/09 Real-Time |
TELIGEN™ Implantable Cardioverter Defibrillator | Boston Scientific CRM St. Paul, MN 55112 |
Approval for the Programmer SW Model 2868 v1.05 for the TELIGEN and COGNIS families of devices. |
| P970012/S053 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P980006/S014 5/5/09 Real-Time |
Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and Bausch & Lomb PureVision 2 (balafilcon A) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Approval for the use of an alternate resin Sunoco D-115A to form the blister package container for the device. |
| P980007/S009 5/28/09 180-Day |
Architect® Free PSA Assay | Abbott Laboratories Abbott Park, IL 60064 |
Approval for migration of the Architect® Free PSA Assay to a new Architect® i System family member, the Architect® i 1000 SR. |
| P980016/S165 5/1/09 180-Day |
Virtuoso DR/VR ICDs, Secura DR/VR ICDs, Maximo II DR/VR ICDs, Virtuoso II DR/VR ICDs |
Medtronic, Inc. Mound View, MN 55112 |
Approval for design and manufacturing process modifications to the existing Medtronic CareLink® Monitor Model 2490C to produce the 2490C low cost monitor. |
| P980016/S184 5/21/09 180-Day |
All Devices except Secura DR/VR Models D224DRG/ D224VRC, Virtuoso II DR/VR Models D274DRG/ D274VRC, and Maximo II DR/VR Models D284DRG/ D284VRC |
Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P980022/S052 5/22/09 Real-Time |
CareLink Pro PC Software | Medtronic MiniMed Northridge, CA 91325 |
Approval for a modification to the CareLink Pro PC Software (Version 1.3A, MMT-7335) to correct two identified problems. |
| P980035/S131 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P980050/S041 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P990001/S052 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P990009/S026 5/4/09 Real-Time |
Floseal Hemostatic Matrix Kit | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Approval for inclusion of two additional product Applicator Tips together as part of the Flowseal Hemostatic Matrix Kit or packaged individually. |
| P990027/S011 5/1/09 180-Day |
Bausch & Lomb Technolas® 217z Zyoptix Laser System for Personalized Vision Correction with a Dynamic Rotational Eye Tracker with Iris Recognition | Bausch & Lomb Surgical, Inc. Rochester, NY 14609 |
Approval for the dynamic rotational eye tracker with iris recognition for use with the Bausch & Lomb Technolas® 217z Zyoptix Laser System for Personalized Vision Correction. The device, as modified, will be marketed under the trade name Technolas® 217z Zyoptix Laser System for Personalized Vision Correction and is indicated for: 1) Wavefront-guided laser assisted in-situ keratomileusis (LASIK) treatments for the reduction or elimination of myopia with sphere up to -7.00 D and cylinder up to -3.00 D and MRSE ≤ 7.50 D at the spectacle plane: Reduction or elimination of myopia (nearsightedness) from -1.00 D to -7.00 D with less than -3.00 D astigmatism; 2) Reduction or elimination of myopic astigmatism up to -12.00 D MRSE, with sphere between ≤7.00 D to -10.99 D and cylinder between 0.00 and ≤3.00 D; and 4) Reduction or elimination of low-to-moderate naturally occurring hyperopia up to +4.00 D MRSE, with sphere between +1.00 D to +4.00 D with or without refractive astigmatism up to +2.00 D at the spectacle plane. |
| P000006/S014 5/29/08 135-Day |
Titan Inflatable Penile Prosthesis (IPP) | Coloplast Corporation Minneapolis, MN 55411 |
Approval for a change in equipment used during the manufacturing dipping process for the device. |
| P000009/S033 5/12/09 180-Day |
Belos, Lexos, Xelos, Lumos, Lumax Families of ICDs | Biotronik, Inc. Lake, Oswego, OR 97035 |
Approval for modification of product labeling for devices that utilize home monitoring. Specifically, supplements requested approval for the replacement of existing precautions and the following marketing statements: 1) Biotronik Home Monitoring information may be used as a replacement for device interrogation during in-office follow-up visits. 2) A strategy of care using Biotronik Home Monitoring with office visits when needed - has been shown to extend the lime between routine, scheduled in-office Follow-ups of Biotronik implantable devices in many patients. Home Monitoring data is helpful in determining the need for additional in-office follow-up. 3) Biotronik Home Monitoring patients -who are followed remotely with office visits when needed - have been shown to have similar numbers of strokes, invasive procedures and deaths as patients followed with conventional in-office follow-ups. 4) Biotronik Home Monitoring provides early detection of arrhythmias. 5) Biotronik Home Monitoring provides early detection of silent, asymptomatic arrhythmias. 6) Automatic early detection of arrhythmias and device system anomalies by Biotronik Home Monitoring allows for earlier intervention than conventional in-office follow-ups. 7) Biotronik Home Monitoring allows for improved access to patient device data compared to conventional in-office follow-ups since device interrogation is automatically scheduled at regular intervals. |
| P000013/S009 5/7/09 Special |
Osteonics® ABC/Trident® Systems | Howmedica Osteonics Corporation Mahwah, NJ 07430 |
Approval for changes to the labeling (i.e., surgical protocol) of the Trident® Hip System. These modifications include creating separate and distinct surgical protocols, one for the Trident® PSL Shell and one for the Trident® Hemispherical Shell, in order to clarify the differences in reaming techniques between the two shells, as well as other improvements to the surgical protocol. |
| P000029/S050 5/21/09 135-Day |
Deflux Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Approval for a change in the testing facility used during manufacturing. |
| P000040/S013 5/14/09 Real-Time |
HTA™ System | Boston Scientific Corporation Marlborough, MA 01752 |
Approval for modifications to the HTA Procedure Sheath (a component of the HTA™ System) which include the addition of the cervical seal assist component and a redesign of the reservoir tip. The sheath, as modified, will be marketed under the trade name HTA™ ProCerva™ Procedure Sheath. |
| P000054/S021 5/13/09 Special |
Infuse® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38136 |
Approval for a modification to the package inserts. Specifically, adding text to one of the Warnings to address AEs and potential surgical interventions associated with improper use of the rhBMP-2/ACS components of the products. |
| P000058/S032 5/13/09 Special |
Infuse® Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38136 |
Approval for a modification to the package inserts. Specifically, adding text to one of the Warnings to address AEs and potential surgical interventions associated with improper use of the rhBMP-2/ACS components of the products. |
| P010003/S013 5/1/09 Special |
BioGlue® Surgical Adhesive | Cryolife, Inc. Kennesaw, GA 30144 |
Approval for changes to the labeling. |
| P010012/S207 5/26/09 Real-Time |
COGNIS™ Cardiac Resynchronization HE Defibrillator | Boston Scientific CRM St. Paul, MN 55112 |
Approval for the Programmer SW Model 2868 v1.05 for the TELIGEN and COGNIS families of devices. |
| P010013/S023 5/8/09 Special |
NovaSure® Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Approval for changes intended to improve the Instructions for Use in regard to safe removal of the NovaSure device following treatment. |
| P010015/S065 5/21/09 180-Day |
CareLink Programmer and all CRT-D, CRT-P, ICDs and Pacemakers | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P010031/S132 5/1/09 180-Day |
Concerto CRT-D, Consulta CRT-D, Maximo II CRT-D, Concerto II CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Approval for design and manufacturing process modifications to the existing Medtronic CareLink® Monitor Model 2490C to produce the 2490C low cost monitor. |
| P010031/S147 5/21/09 180-Day |
All Devices except Consulta Model D224TRK, Concerto II Model D274TRK, and Maximo II Model D284TRK | Medtronic, Inc. Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe for the 2090X CareLink Programmer. |
| P010055/S055 5/21/09 180-Day |
CoreTherm System Microwave Thermotherapy for BPH | ProstaLund Operations AB Lund, Sweden SE-226 60 |
Approval for a manufacturing site located at Sterigenics Germany, Wiesbaden, Germany. |
| P010059/S003 5/22/09 Real-Time |
Morcher Capsular Tension Rings and Morcher EYEJET CTR | Morcher GmbH Centerville, MA 02632 |
Approval for the addition of capsular tension rings (CTRs) models 1G, 2S, 6D, 6E, and 10C and change in packaging to incorporate the Morcher injector preloaded with CTR models 14, 14A, and 14C. The device, as modified, will be marketed under the trade name Morcher Capsular Tension Rings (Models 1G, 2S, 6D, 6E, and 10C) and EYEJET CTR and is indicated for the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation. Conditions associated with weak or partially absent zonules may include primary zonular weakness (e.g., Marfan's Syndrome), secondary zonular weakness (e.g., trauma or vitrectomy), cases of zonulysis, cases of pseudoexfoliation and cases of Marchesani’s Syndrome. |
| P020009/S036 5/15/09 Real-Time |
Express 2™ Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval to update the information in the Instructions for Use related to Magnetic Resonance Imaging (MRI) compatibility. |
| P030006/S017 5/18/09 180-Day |
Prolieve Thermodilitation System | Boston Scientific Corporation Marlborough, MA 01752 |
Approval for a rectal temperature monitor which is disposable. The disposable rectal temperature monitor will be contract manufactured at Phillips Plastic Corporation, Short-Run facility (Phillips Short-Run) located in Richmond, Wisconsin. |
| P030017/S085 5/1/09 135-Day |
Precision® Spinal Cord Stimulation (SCS) System | Boston Scientific Neuromodulation Corporation Sylmar, CA 91342 |
Approval for a modification to processing equipment at a contract vendor. |
| P030025/S044 5/15/09 Real-Time |
Taxus™ Express 2™ Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Approval to update the information in the Instructions for Use related to Magnetic Resonance Imaging (MRI) compatibility. |
| P030054/S114 5/7/09 180-Day |
Atlas II + HF CRT-D and Promote HE CRT-D |
St. Jude Medical Sylmar, CA 91342 |
Approval of the post-approval study protocol. |
| P030054/S122 5/7/09 Real-Time |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Sylmar, CA 91342 |
Approval for: 1) Replacing the existing hand solder interconnections between subassemblies with plug/receptacle connectors, epoxy, direct solder or laser welding. 2) Using an organic substrate for the hybrid module. 3) Reconfiguring discrete surface mount magnetic components (e.g. HV converter board assembly, sensor support assembly) to integrate them into the hybrid. |
| P040016/S022 5/15/09 Real-Time |
Liberté Coronary Stent System |
Boston Scientific Corporation Maple Grove, MN 55311 |
Approval to update the information in the Instructions for Use related to Magnetic Resonance Imaging (MRI) compatibility. |
| P040020/S015 5/28/09 Real-Time |
AcrySof® IQ ReSTOR® Intraocular Lenses | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for an expansion of the dioptric range to include 6.0 to 9.5 diopters in ½ diopter increments for models SN6AD1, MN6AD1 and SN6AD3. |
| P040021/S008 5/4/09 180-Day |
Biocor Valve and Biocor Supra Valve | St. Jude Medical Cardiac Surgery Division St. Paul, MN 55117 |
Approval of the post-approval study protocol. |
| P040038/S018 5/7/09 180-Day |
Xact Carotid Stent System | Abbott Vascular, Inc. Santa Clara, CA 95054 |
Approval for a manufacturing site located at Abbott Vascular Corporation, Temecula, California, and a sterilization site located at Sterigenics, Los Angeles, California. |
| P040044/S014 5/12/09 Special |
Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 |
Approval for changes to the Patient Brochure. |
| P040051/S001 5/8/09 135-Day |
Stelkast Surpass™ Acetabular System | Stelkast Company Mc Murray, PA 15317 |
Approval for implementation of new software to the manufacturing line to allow polished inserts to be reworked, following inspection, in one of the two inner sphere polishing stations, while the other station continues to be used for initial production. |
| P050007/S013 5/1/09 Real-Time |
StarClose SE Vascular Closure System | Abbott Vascular, Inc. Redwood City, CA 94063 |
Approval for the addition of a fin to the pusher block component of the device. |
| P050012/S018 5/5/09 Real-Time |
DexCom Seven Systems | DexCom, Inc. San Diego, CA 92121 |
Approval for design revisions to the accessory software program to provide additional supplementary information to users on glucose trends and patterns downloaded to the program. The software program, as modified, will be marketed under the trade name DexCom Data Manager 3 (DM3) and is indicated for use by consumers to allow for the transfer of glucose data stored by the DexCom STS or Seven Systems into a personal computer (PC). The software modifications included several new features as identified in the submission. |
| P050020/S012 5/8/09 Real-Time |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Approval for modifications to the Inserter component housing of the FreeStyle CGMS, to reduce the overall thickness in the shelves of the housing and a change to the manufacturing equipment used to mold the housing components. |
| P050023/S020 5/12/09 180-Day |
Kronos, Lumax Families of CRT-Ds | Biotronik, Inc. Lake, Oswego, OR 97035 |
Approval for modification of product labeling for devices that utilize home monitoring. Specifically, supplements requested approval for the replacement of existing precautions and the following marketing statements: 1) Biotronik Home Monitoring information may be used as a replacement for device interrogation during in-office follow-up visits. 2) A strategy of care using Biotronik Home Monitoring with office visits when needed - has been shown to extend the lime between routine, scheduled in-office Follow-ups of Biotronik implantable devices in many patients. Home Monitoring data is helpful in determining the need for additional in-office follow-up. 3) Biotronik Home Monitoring patients -who are followed remotely with office visits when needed - have been shown to have similar numbers of strokes, invasive procedures and deaths as patients followed with conventional in-office follow-ups. 4) Biotronik Home Monitoring provides early detection of arrhythmias. 5) Biotronik Home Monitoring provides early detection of silent, asymptomatic arrhythmias. 6) Automatic early detection of arrhythmias and device system anomalies by Biotronik Home Monitoring allows for earlier intervention than conventional in-office follow-ups. 7) Biotronik Home Monitoring allows for improved access to patient device data compared to conventional in-office follow-ups since device interrogation is automatically scheduled at regular intervals. |
| P060008/S008 5/21/09 Panel |
Taxus® Liberté® Atom™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems) | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 |
Approval to expand the product matrix to include the 2.25 mm Taxus® Liberté ® Paclitaxel-Eluting Coronary Stent System. This device size will be marketed under the trade name Taxus® Liberté ® Atom™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems), and is indicated for improving luminal diameter for the treatment of de novo lesions in native coronary arteries ≥ 2.25 mm to ≤ 4.00 mm in diameter in lesions ≤ 28 mm in length. |
| P060008/S010 5/7/09 135-Day |
Taxus Liberté Paclitaxel-Eluting Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for an additional sterilization chamber at Isotron Ireland, Ltd. |
| P060008/S016 5/22/09 180-Day |
Taxus Liberté Paclitaxel-Eluting Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for a manufacturing site located in Plymouth, Minnesota, for the manufacture of SIBS polymer. |
| P060010/S005 5/19/09 Special |
Spanner™ Temporary Prostatic Stent | AbbeyMoor Medical, Inc. Parkers Prairie, MN 56361 |
Approval for the addition of an in-process inflation test for the Insertion Tool. |
| P070007/S003 5/21/09 135-Day |
Medtronic Vascular Talent Thoracic Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a modification to the current manufacturing process used by the supplier of stent components for the device. |
| P070008/S009 5/12/09 180-Day |
Stratos Family of CRT-Ps | Biotronik, Inc. Lake, Oswego, OR 97035 |
Approval for modification of product labeling for devices that utilize home monitoring. Specifically, supplements requested approval for the replacement of existing precautions and the following marketing statements: 1) Biotronik Home Monitoring information may be used as a replacement for device interrogation during in-office follow-up visits. 2) A strategy of care using Biotronik Home Monitoring with office visits when needed - has been shown to extend the lime between routine, scheduled in-office Follow-ups of Biotronik implantable devices in many patients. Home Monitoring data is helpful in determining the need for additional in-office follow-up. 3) Biotronik Home Monitoring patients -who are followed remotely with office visits when needed - have been shown to have similar numbers of strokes, invasive procedures and deaths as patients followed with conventional in-office follow-ups. 4) Biotronik Home Monitoring provides early detection of arrhythmias. 5) Biotronik Home Monitoring provides early detection of silent, asymptomatic arrhythmias. 6) Automatic early detection of arrhythmias and device system anomalies by Biotronik Home Monitoring allows for earlier intervention than conventional in-office follow-ups. 7) Biotronik Home Monitoring allows for improved access to patient device data compared to conventional in-office follow-ups since device interrogation is automatically scheduled at regular intervals. |
| P070016/S004 5/21/09 180-Day |
Zenith® TX2® Thoracic TAA Endovascular Graft | Cook, Inc. Bloomington, IN 47404 |
Approval for minor changes to the proximal trigger-wire attachment and tapered section of the pusher. |
| P070027/S003 5/21/09 135-Day |
Medtronic Vascular Talent Abdominal Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval for a modification to the current manufacturing process used by the supplier of stent components for the device. |
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/S041 5/20/09 |
HEMA for Vistakon® (etafilcon A) Soft Hydrophilic Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Change to implement an alternate supplier for the critical material, HEMA, used in the production of the device. |
| P810046/S231 5/26/09 |
Voyager™ NC Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 |
Change from a manually performed operation to an automated operation. |
| P830055/S110 5/6/09 |
LCS Total Knee System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Use of two new automated clean lines to replace the existing automated cleaning system used to remove manufacturing materials. |
| P860003/S053 5/27/09 |
CellEx Photopheresis System | Therakos, Inc. Raritan, NJ 08869 |
Change to perform final product testing on CellEx procedural kits at a contract manufacturer. |
| P860004/S105 5/14/09 |
SynchroMed Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of visual inspections of the pump septums in manufacturing. |
| P860004/S107 5/1/09 |
SynchroMed II Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Changes to the pump tube component of the device. |
| P860019/S235 5/13/09 |
Apex PTCA Balloon Dilation Catheter (Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the supplier of the Over-the-Wire manifold component. |
| P860019/S236 5/8/09 |
Apex Monorail and Over-the-Wire PTCA Catheters | Boston Scientific Corporation Maple Grove, MN 55311 |
Removal of a redundant verification step. |
| P890003/S171 5/8/09 |
CapSure VDD Lead | Medtronic, Inc. Mound View, MN 55112 |
Change in the connector sleeve supplier. |
| P900056/S096 5/22/09 |
Rotablator™ Rotational Atherectomy System – RotaWire Guidewire | Boston Scientific Corporation Maple Grove, MN 55311 |
Modifications to the drawing specifications for the RotaWire guidewire. |
| P930038/S058 5/7/09 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical, Inc. Maple Grove, MN 55311 |
Change from a manual to an automated process for the Evolution assembly. |
| P930039/S032 5/8/09 |
CapSureFix Novus Lead | Medtronic, Inc. Mound View, MN 55112 |
Change in the connector sleeve supplier. |
| P950005/S026 5/13/09 |
Celsius RMT Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Removal of an inspection step. |
| P950029/S044 5/1/09 |
Symphony SR 2250 Pacemaker, Symphony DR 2550 Pacemaker, Rhapsody SR 2210 Pacemaker, Rhapsody DR 2510 Pacemaker, Rhapsody DR 2530 Pacemaker, Reply VR Pacemaker and Reply DR Pacemaker |
ELA Medical, Inc. Plymouth, MN 55441 |
Improvement in manufacturing Bal Seal verification. |
| P960040/S194 5/21/09 |
Confient, Prizm and Vitality Models | Guidant Corporation St. Paul, MN 55112 |
Change in the incoming lot acceptance testing and criteria for thin-film resistor components. |
| D970003/S110 5/21/09 |
Insignia, Altrua and Nexus Models | Guidant Corporation St. Paul, MN 55112 |
Change in the incoming lot acceptance testing and criteria for thin-film resistor components. |
| D970012/S067 5/20/09 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Change in the molding process for the device. |
| P980016/S193 5/8/09 |
Secura DR/VR, Maximo II DR/VR, and Virtuoso II DR/VR Families of Implantable Cardioverter Defibrillators (ICDs) | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the device functional test software. |
| P980022/S054 5/22/09 |
SOF-SENSOR Glucose Sensor | Medtronic MiniMed Northridge, CA 91325 |
Changes to the sensor base and the needle/hub components. |
| P980049/S047 5/1/09 |
Ovation VR 6250 ICD and Ovation DR 6550 ICD | ELA Medical, Inc. Plymouth, MN 55441 |
Improvement in manufacturing Bal Seal verification. |
| P980049/S048 5/8/09 |
Ovation VR 6250 ICD and Ovation DR 6550 ICD | ELA Medical, Inc. Plymouth, MN 55441 |
Change in the glue barrier disposal process. |
| P990025/S018 5/13/09 |
Navistar RMT Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Removal of an inspection step. |
| P990046/S021 5/12/09 |
ATS Medical Open Pivot Bi-Leaflet Mechanical Heart Valve | ATS Medical, Inc. Minneapolis, MN 55447 |
Additional CNC grinder. |
| P000029/S055 5/5/09 |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Use of two new test methods for the determination of two chemical entities in the gel. |
| P000029/S056 5/27/09 |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Use of a new incoming identification test method for a chemical entity in the gel as well as a new testing facility for this identification test method. |
| P010012/S208 5/21/09 |
Renewal and Livian Models | Guidant Corporation St. Paul, MN 55112 |
Change in the incoming lot acceptance testing and criteria for thin-film resistor components. |
| P010025/S016 5/1/09 |
Selenia Full Field Digital Mammography System | Hologic, Inc. Danbury, CT 06810 |
Change to the computer housing. |
| P010031/S154 5/8/09 |
Consulta, Maximo II, Concerto II Families of Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
Medtronic, Inc. Mounds View, MN 55112 |
Changes to the device functional test software. |
| P010068/S014 5/13/09 |
Navistar RMT DS Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Removal of an inspection step. |
| P020011/S001 5/22/09 |
VERSANT® HCV RNA Qualitative Assay and the APTIMA® HCV RNA Qualitative Assay | Gen-Probe, Inc. San Diego, CA 92121 |
Change of the activator used in the synthesis of DNA oligonucleotides from 1-H Tetrazole to 5-Ethylthio 1-H Tetrazole (ETT) and the addition of Sigma-Aldrich (SAFC) as a secondary supplier of the new activator (ETT). |
| P020022/S008 5/1/09 |
Versant HCV RNA 3.0 Assay (bDNA) | Siemens Healthcare Diagnostics East Walpole, MA 02032 |
Addition of an incoming quality control step. |
| P020026/S063 5/6/09 |
Cypher® Sirolimus-Eluting Coronary Stent on Raptor™ Over-the-Wire Delivery System or Raptorrail® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Change to an acceptance criterion for an in-process acceptance activity. |
| P030005/S057 5/21/09 |
Renewal TR Models | Guidant Corporation St. Paul, MN 55112 |
Change in the incoming lot acceptance testing and criteria for thin-film resistor components. |
| P030049/S006 5/27/09 |
ADVIA Centaur HBsAg Confirmatory Assay | Siemens Healthcare Diagnostics East Walpole, MA 02032 |
Change of critical raw material supplier. |
| P040045/S004 5/13/09 |
Vistakon® (senofilcon A) Contact Lenses for Extended Wear | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Use of an alternate finished product release test method. |
| P060008/S015 5/7/09 |
Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an intra-campus manufacturing site incorporating the specified process changes. |
| P060008/S017 5/26/09 |
Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Change in the supplier sampling plan for the hypotube component. |
| P060010/S006 5/27/09 |
The Spanner Temporary Prostatic Stent | AbbeyMoor Medical, Inc. Parkers Prairie, MN 56351 |
Change to the cosmetics of a Spanner component. |
| P060027/S013 5/1/09 |
Ovation CRT 6750 | ELA Medical, Inc. Plymouth, MN 55441 |
Improvement in manufacturing Bal Seal verification. |
| P060027/S014 5/8/09 |
Ovation CRT 6750 | ELA Medical, Inc. Plymouth, MN 55441 |
Change in the glue barrier disposal process. |
| P060030/S003 5/22/09 |
COBAS AmpliPrep/ COBAS Taqman HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Change of functional release testing of bulk Magnetic Glass Particles (MGP), Proteinase (Pase), Elution Buffer (EB), and Lysis Buffer (LB) for the device. |
| P060037/S008 5/8/09 |
Nexgen LPS-Flex / LPS-Mobile Bearing Knee | Zimmer, Inc. Warsaw, IN 46581 |
Changes in the packaging clean room for the device. |
| P070015/S015 5/8/09 |
Xience V® and Promus™ Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 |
Extension of the retest date for one of the polymers used in the manufacture of the device. |
| P070015/S016 5/29/09 |
Xience V® and Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Temecula, CA 92590 |
Modifications ot the particulate testing. |
| P080006/S001 5/8/09 |
Attain Ability Lead | Medtronic, Inc. Mounds View, MN 55112 |
Modification of the acceptance criteria of the ethylene oxide sterilization manufacturing process at the MPROC-Villalba facility. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 71
Summary of PMA Originals Under Review
Total Under Review: 67
Total Active: 28
Total On Hold: 39
Number Greater Than 180 Days: 9
Summary of PMA Supplements Under Review
Total Under Review: 458
Total Active: 291
Total On Hold: 167
Number Greater Than 180 Days: 23
Summary of All PMA Submissions Received
Originals: 4
Supplements: 106
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 71
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 163
FDA Time: 116.3 Days MFR Time: 46.7 Days
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