Medical Devices
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January 2010 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 |
|---|---|---|---|
| P010047 1/14/10 | ProGel™ Pleural Air Leak Sealant | NeoMend, Inc. Irvine, CA 92618 | Approval for ProGel™ Pleural Air Leak Sealant. The device is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (≥2 mm) incurred during open resection of lung parenchyma. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P830061/S047 1/21/10 Real-Time | Capsure SP Novus Leads and Capsure SP Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P850079/S046 1/29/10 135-Day | Frequency Toric (Methafilcon A 55%) Soft (Hydrophilic) Contact Lenses | CooperVision, Inc. Norfolk, VA 23507 | Approval for the migration from a manual to an automatic wet lens inspection system. |
| P850089/S062 1/21/10 Real-Time | Capsure Z Novus Leads, Capsure Z Leads, Capsure SP Leads and Capsure SP Novus Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P860057/S062 1/5/10 Real-Time | Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 | Approval for elimination of stent creep testing from the shelf life testing protocol for the PERIMOUNT® bioprosthetic valves treated with the ThermaFix process. |
| P890003/S175 1/21/10 Real-Time | Prodigy IPG and Capsure VDD Leads | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P900066/S009 1/13/10 Special | ISPAN Perfluoropropane C3F8 Gas | Air Liquide Healthcare America Corporation Plumsteadville, PA 18949 | Approval for changes to the labeling to include clarification of the gas pressure restriction listed on the gas cylinder label and enhanced instruction for filling a syringe with ISPAN Perfluoropropane C3F8 Gas. |
| P900067/S006 1/13/10 Special | ISPAN Sulfur Hexafluoride SF6 Gas | Air Liquide Healthcare America Corporation Plumsteadville, PA 18949 | Approval for changes to the labeling to include clarification of the gas pressure restriction listed on the gas cylinder label and enhanced instruction for filling a syringe with ISPAN Hexafluoride SF6 Gas. |
| P910023/S215 1/29/10 180-Day | Cadence ICD System | St. Jude Medical, Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the Current Accel ICD models CD2215/CD1215 and Promote Accel CRT-D model CD3215 Pulse Generators and the Model 3330 Version 7.1.2.1. |
| P930027/S010 1/21/10 180-Day | IMMULITE®/ IMMULITE® 1000, IMMULITE® 2000, IMMULITE® 2500 PSA and IMMULITE®/ IMMULITE® 1000, IMMULITE® 2000, IMMULITE® 2500 3 rd Generation PSA | Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 | Approval for a manufacturing site located at Siemens Healthcare Diagnostics in Newark, Delaware. |
| P930039/S033 1/21/10 Real-Time | CapsureFix Novus Lead, SureFix Lead | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P950037/S074 1/22/10 Real-Time | Actros, Axios, Kairos, Cylos, Dromos, Philos, and Philos II Families of Pacemaker Pulse Generators and Pacemaker Programmers | Biotronik, Inc. Lake Oswego, OR 97035 | Approval to implement hardware changes to the ICS 3000 Implant Control System. |
| P950037/S076 1/22/10 Real-Time | Actros, Axios, Kairos, Cylos, Dromos, Philos, and Philos II Families of Pacemaker Pulse Generators and Pacemaker Programmers | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for a software upgrade to version 902.U/1. This software is used in the ICS 3000 system to program and interrogate all of Biotronik’s US market released bradycardia and tachycardia pacemakers. |
| P960013/S052 1/20/10 135-Day | Tendril Family of Leads | St. Jude Medical, CRDM Sylmar, CA 91342 | Approval for a new lead component supplier. |
| D970003/S113 1/8/10 Real-Time | ALTRUA Family of Pacemakers | Boston Scientific Corporation St, Paul, MN 55112 | Approval for setscrew and seal plug design changes, torque wrench labeling changes, and some associated manufacturing changes to ALTRUA pacemaker models S208, S404, and S606. |
| P970004/S069 1/14/10 Real-Time | Medtronic InterStim® Therapy for Urinary Control | Medtronic Neuromodulation Minneapolis, MN 55432 | Approval for material grade change to the Model 3550-05 Temporary Percutaneous Extension ETFE Material. |
| P970012/S058 1/21/10 Real-Time | Kappa 400 DR IPG and Kappa 400 SR IPG | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P980016/S208 1/13/10 180-Day | Secura DR/VR, Maximo II DR/VR, Virtuoso II VR/DR | Medtronic, Inc. Mounds View, MN 55112 | Approval for a manufacturing site located at Medtronic Swiss Manufacturing Operations in Tolochenaz, Switzerland to perform final packaging for the device. |
| P980016/S209 1/21/10 Real-Time | Marquis ICD Family, Maximo ICD Family, Intrinsic ICD Family, Entrust ICD Family | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P980035/S145 1/21/10 Real-Time | Adapta, Versa, Sensia, and Relia Family of Pacemakers | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P980035/S146 1/13/10 180-Day | Adapta, Versa, Sensia, and Relia | Medtronic, Inc. Mounds View, MN 55112 | Approval for a manufacturing site located at Medtronic Swiss Manufacturing Operations in Tolochenaz, Switzerland to perform final packaging for the device. |
| P980040/S029 1/22/10 180-Day | TECNIS® Multifocal 1-Piece Intraocular Lens (IOL) | Abbott Medical Optics, Inc. Santa Ana, CA 92705 | Approval for the TECNIS® Multifocal 1-Piece Intraocular Lens (IOL), Model ZMB00. |
| P990001/S057 1/21/10 Real-Time | C-series IPG Devices, T-Series IPG Devices, Dema Family | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P990009/S025 1/7/10 180-Day | Floseal Hemostatic Matrix 5ml/10ml Kit | Baxter Healthcare Corporation McGaw Park, IL 60085 | Approval for inclusion of human thrombin that has been treated with a second viral inactivation step (solvent detergent process) in the Floseal Hemostatic Matrix Kit as well as approval for associated labeling changes to reflect the additional viral inactivation step for the thrombin component. |
| P990020/S036 1/21/10 135-Day | AneuRx AAAdvantage Stent Graft Delivery System | Medtronic Vascular Santa Rosa, CA 95403 | Approval for a change in the manufacturing location of the device within the Medtronic Ireland campus. |
| P990038/S012 1/12/10 Real-Time | ETI-MAK-2 PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 | Approval for a change in the sample stability claim for 48 hours at 2-8° C to 8 days at 2-8° C and modifications of the labeling to reflect the change. |
| P990041/S011 1/12/10 Real-Time | ETI-AB-EBK PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 | Approval for a change in the sample stability claim for 48 hours at 2-8° C to 6 days at 2-8° C and modifications of the labeling to reflect the change. |
| P990043/S012 1/12/10 Real-Time | ETI-EBK PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 | Approval for a change in the sample stability claim for 48 hours at 2-8° C to 6 days at 2-8° C and modifications of the labeling to reflect the change. |
| P990044/S009 1/12/10 Real-Time | ETI-CORE-IGMK PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 | Approval for a change in the sample stability claim for 48 hours at 2-8° C to 8 days at 2-8° C and modifications of the labeling to reflect the change. |
| P990045/S009 1/12/10 Real-Time | ETI-AB-COREK PLUS Assay | DiaSorin, Inc. Stillwater, MN 55082 | Approval for a change in the sample stability claim for 48 hours at 2-8° C to 8 days at 2-8° C and modifications of the labeling to reflect the change. |
| P000009/S038 1/22/10 Real-Time | Belos, Lexos, Lumos, and Xelos Families of ICDs and ICD Programmers | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for a software upgrade to version 902.U/1. This software is used in the ICS 3000 system to program and interrogate all of Biotronik’s US market released bradycardia and tachycardia pacemakers. |
| P000014/S019 1/11/10 180-Day | VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and VITROS Immunodiagnostic Products Anti-HBs Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 | Approval for revision of the Intended Use to include use of the VITROS 5600 Integrated System and VITROS 3600 Immunodiagnostic System with the VITROS Immunodiagnostic Products Anti-HBs Assay. The device, as modified, will be marketed under the trade names VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, VITROS Immunodiagnostic Products Anti-HBs Calibrator, and is indicated for: VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack: For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti- HBs) in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory' diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis, in whom etiology is unknown. VITROS Immunodiagnostic Products Anti-HBs Calibrator: For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum using the VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack. |
| P000020/S013 1/21/10 Special | Stinger, Stinger M, Stinger S, Stinger SM, Scorpion, Scorpion M, Scorpion *2, Scorpion *2M Ablation Catheters | C.R. Bard, Inc. Lowell, MA 01851 | Approval for the addition of a warning to the instructions for use stating: “Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.” |
| P000032/S030 1/20/10 Real-Time | Her Option™ Uterine Cryoablation Therapy System™ | American Medical Systems Minnetonka, MN 55434 | Approval for a change to the refrigerant blend used in the Gas Mix Compressor (GMC) of the Her Option™ console. |
| P000037/S017 1/14/10 Real-Time | On-X® Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78754 | Approval to change the material specifications for the sewing cuff PTFE fabric used in the assembly of the On-X Valve. |
| P000054/S019 1/20/10 135-Day | Infuse® Bone Graft | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 | Approval for an additional supplier of bovine Achilles tendon for the manufacture of the Absorbable Collagen Sponge (ACS) component of the Infuse Bone Graft. |
| P000054/S023 1/14/10 135-Day | Infuse® Bone Graft | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 | Approval for the removal of Ellman’s Assay and SDS-PAGE Silver Stain Tests from the rhBMP-2 drug substance release specification. |
| P000058/S030 1/20/10 135-Day | Infuse® Bone Graft/LT CAGE Lumbar Tapered Fusion Device | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 | Approval for an additional supplier of bovine Achilles tendon for the manufacture of the Absorbable Collagen Sponge (ACS) component of the Infuse Bone Graft. |
| P000058/S034 1/14/10 135-Day | Infuse® Bone Graft/LT CAGE Lumbar Tapered Fusion Device | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 | Approval for the removal of Ellman’s Assay and SDS-PAGE Silver Stain Tests from the rhBMP-2 drug substance release specification. |
| P010007/S004 1/21/10 180-Day | IMMULITE®/ IMMULITE® 1000, IMMULITE® 2000, IMMULITE® 2500 AFP | Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 | Approval for a manufacturing site located at Siemens Healthcare Diagnostics in Newark, Delaware. |
| P010013/S026 1/12/10 Real-Time | NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 | Approval for the addition of Smooth Access Tips to the tips of the NovaSure Disposable Array. |
| P010015/S073 1/21/10 Real-Time | InSync CRT-P, InSync III CRT-P, Attain OTW Lead, Attain Bipolar OTW Lead, Attain CS Lead and Attain LV Lead | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P010031/S169 1/13/10 180-Day | Consulta CRT-D, Maximo II CRT-D, and Concerto II CRT-D | Medtronic, Inc. Mounds View, MN 55112 | Approval for a manufacturing site located at Medtronic Swiss Manufacturing Operations in Tolochenaz, Switzerland to perform final packaging for the device. |
| P010031/S170 1/21/10 Real-Time | Insync II Marquis ICD | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P010033/S014 1/29/10 135-Day | QuantiFERON - TB Gold and QuantiFERON - TB Gold In-Tube | Cellestis, Inc. Valencia, CA 91355 | Approval for the use of the Dry Room at Scantibodies Laboratory, Inc., Santee, California, to be used as an alternative method to vacuum drying in the manufacturing process of ELISA plates. |
| P010033/S015 1/25/10 135-Day | QuantiFERON - TB Gold In-Tube | Cellestis, Inc. Valencia, CA 91355 | Approval to allow the use of dry peptides to be formulated at Cellestis and shipped to the contract manufacturer for the manufacture of TB Antigen blood collection tubes. |
| P010050/S010 1/20/10 180-Day | IMMULITE/ IMMULITE 1000, IMMULITE 2000 HBsAg and Confirmatory | Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 | Approval for a manufacturing site located at Siemens Healthcare Diagnostics, Newark, Delaware for IMMULITE Substrate manufacturing. |
| P010051/S007 1/20/10 180-Day | IMMULITE/ IMMULITE 1000, IMMULITE 2000 HBc | Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 | Approval for a manufacturing site located at Siemens Healthcare Diagnostics, Newark, Delaware for IMMULITE Substrate manufacturing. |
| P010052/S007 1/20/10 180-Day | IMMULITE/ IMMULITE 1000, IMMULITE 2000 HBs | Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 | Approval for a manufacturing site located at Siemens Healthcare Diagnostics, Newark, Delaware for IMMULITE Substrate manufacturing. |
| P010053/S006 1/20/10 180-Day | IMMULITE/ IMMULITE 1000, IMMULITE 2000 HBc IgM | Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 | Approval for a manufacturing site located at Siemens Healthcare Diagnostics, Newark, Delaware for IMMULITE Substrate manufacturing. |
| P010054/S011 1/7/10 Real-Time | Elecsys Anti-HBs Test System, Anti-HBs CalCheck | Roche Diagnostics Indianapolis, IN 46250 | Approval for the extension of the Anti-HBs CalCheck shelf-life from nine months to fourteen months when stored at 2-8 degrees C. |
| P020016/S004 1/29/10 Real-Time | Total Temporomandibular Joint Replacement System | Walter Lorenz Surgical, Inc. Jacksonville, FL 32218 | Approval for changes to the packaging materials of both the Fossa and the Mandibular TMJ System components, and extension of the shelf life of these devices to 5 years. |
| P030054/S131 1/29/10 180-Day | Epic HF CRT-D System | St. Jude Medical, Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the Current Accel ICD models CD2215/CD1215 and Promote Accel CRT-D model CD3215 Pulse Generators and the Model 3330 Version 7.1.2.1. |
| P040001/S012 1/28/10 180-Day | X-STOP Interspinous Process Decompression (IPD) | Medtronic Spine, LLC Sunnyvale, CA 94089 | Approval for a labeling change to add placement of the patient in the prone position during implantation of the device. |
| P040002/S024 1/6/10 135-Day | Powerlink® System with IntuiTrack Delivery System™ | Endologix, Inc. Irvine, CA 92618 | Approval for a change in graft processing procedures. |
| P040024/S039 1/29/10 180-Day | Restylane-L and Perlane-L Injectable Gels | Medicis Aesthetics Holding, Inc. Scottsdale, AZ 85256 | Approval for the addition of 0.3% lidocaine into Restylane and Perlane. The device, as modified, will be marketed under the trade names Restylane-L and Perlane-L and is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds; and for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, respectively. |
| P050007/S023 1/27/10 Real-Time | Starclose SE Vascular Closure System | Abbott Vascular Devices Redwood City, CA 94063 | Approval to increase the clearance of the clip delivery tube and minor modifications to the exchange system and sheath splitter for the device. |
| P050020/S017 1/19/10 Real-Time | FreeStyle Navigator® Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 | Approval for a process validation on the Sharp manufactured at Oberg Industries (in Freeport, Pennsylvania) as well as to widen dimensional tolerances on the Sharp in both length and angle bend. Currently all sharps produced at Oberg must undergo 100% inspection at Facet (in Marietta, Georga) prior to its assembling into the Sensor Inserter of the Sensor Delivery Unit (SDU) of the FreeStyle Navigator® Continuous Glucose Monitoring System. The process validation provided in this supplement will replace the 100% inspection requirement at Facet. |
| P050020/S021 1/11/10 Special | FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 | Approval for labeling changes for the FreeStyle Navigator User’s Guide as follows: 1) Addition of the statement under the “Specifications” section” “Store the test strips between 40 degrees F and 86 degrees F.”; 2) Addition of the statement under the “Important notes” section: “The system is intended for your personal use; do NOT share your system with others.” |
| P050023/S028 1/22/10 Real-Time | Lumax and Kronos Families of CRT-Ds | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for a software upgrade to version 902.U/1. This software is used in the ICS 3000 system to program and interrogate all of Biotronik’s US market released bradycardia and tachycardia pacemakers. |
| P050047/S005 1/7/10 180-Day | Juvederm Ultra XC and Juvederm Ultra Plus XC | Allergan Goleta, CA 93117 | Approval for the addition of 0.3% lidocaine into Juvederm Ultra and Juvederm Ultra Plus. The device, as modified, will be marketed under the trade name Juvederm Ultra XC and Juvederm Ultra Plus XC and is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). |
| P050053/S010 1/20/10 135-Day | Infuse® Bone Graft | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 | Approval for an additional supplier of bovine Achilles tendon for the manufacture of the Absorbable Collagen Sponge (ACS) component of the Infuse Bone Graft. |
| P050053/S013 1/14/10 135-Day | Infuse® Bone Graft | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 | Approval for the removal of Ellman’s Assay and SDS-PAGE Silver Stain Tests from the rhBMP-2 drug substance release specification. |
| P060005/S003 1/21/10 180-Day | IMMULITE®/ IMMULITE® 1000, IMMULITE® 2000 Free PSA | Siemens Healthcare Diagnostics, Inc. East Walpole, MA 02032 | Approval for a manufacturing site located at Siemens Healthcare Diagnostics in Newark, Delaware. |
| P060008/S034 1/29/10 | Taxus® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for a manufacturing site located at STERIS Isomedix Services, Inc., in Coventry, Rhode Island. |
| P060039/S007 1/21/10 Real-Time | Attain StarFix Lead | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
| P060040/S005 1/20/10 Panel | Thoratec HeartMate II® Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 | Approval for the Thoratec HeartMate II® LVAS. The device is indicated for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. It is now also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days, and are not candidates for cardiac transplantation. The HeartMate II® LVAS is intended for use both inside and outside the hospital, or for transportation of ventricular assist device patients via ground ambulance, fixed-wing aircraft, or helicopter. |
| P070008/S014 1/22/10 Real-Time | Stratos LV/LV-T Family of CRT-Ps | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for a software upgrade to version 902.U/1. This software is used in the ICS 3000 system to program and interrogate all of Biotronik’s US market released bradycardia and tachycardia pacemakers. |
| P080006/S003 1/21/10 Real-Time | Attain Ability LV Lead | Medtronic, Inc. Mounds View, MN 55112 | Approval for reformulation of the hotmelt adhesive that is used in Medtronic CRDM sterile barrier packages. |
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 |
|---|---|---|---|
| P810032/S055 1/22/10 | PMMA Intraocular Lenses | Alcon Research, Ltd. Tort Worth, TX 76134 | Change in the Bar-Sealer Monitoring System. |
| P830060/S064 1/12/10 | Accessories Model Numbers: 0010,0012, 0013,0014, 0015,0040, 4312,4313, 6501,6503,6504, 6517, 6526, 6529, 6541,6634, 6810, 6811,6826,6828,6830,6836, 6902, 6910, 6941,6983, and 6985 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P830060/S065 1/15/10 | Ventak ICDs | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P840001/S142 1/13/10 | Implantable Neurostimulators for Spinal Cord Stimulation | Medtronic Neuromodulation Minneapolis, MN 55432 | Increasing the bake time for ceramic substrates prior to the solder prep reflow and adding an additional bake after the clean and dry processing step. |
| P840001/S144 1/21/10 | RestorePRIME Implantable Neurostimulator, PrimeADVANCED Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Increase in the press force used to form the battery cathodes which will reduce the cathode thickness variation and increase the yield of the RX1 battery production. |
| P840060/S032 1/22/10 | PMMA Intraocular Lenses | Alcon Research, Ltd. Tort Worth, TX 76134 | Change in the Bar-Sealer Monitoring System. |
| P860057/S064 1/12/10 | Carpentier-Edwards® Perimount® Pericardial Bioprosthesis | Edwards Lifesciences, LLC | Addition of two existing models to those already approved for the Changi, Singapore facility and to perform a final assembly step at this facility in addition to the Irvine and Howr facilities. |
| P870056/S037 1/14/10 | Carpentier-Edwards Porcine Bioprosthesis & Carpentier-Edwards Bioprosthetic Valved Conduit | Edwards Lifesciences LLC Irvine, CA 92614 | Addition of alternate material suppliers. |
| P870077/S034 1/14/10 | Carpentier-Edwards Duraflex Mitral Low Pressure Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Addition of alternate material suppliers. |
| P880003/S100 1/20/10 | PTCA Dilation Catheters and FIRESTAR™ Rx PTCA Balloon Dilation Catheter | Cordis Corporation Bidgewater, NJ 08807 | Alternate manufacturing facility for an extrusion process. |
| P880086/S184 1/22/10 | AddVent, Affinity, Identity, Verity, Integrity, Victory, Zephyr, Accent, Triology, Synchrony, Paragon, an d Phonenix Low Voltage Pulse Generators | St. Jude Medical, CRDM Sylmar, CA 91342 | Change in the process water system monitoring frequency and locations at Arecibo, Puerto Rico manufacturing facility. |
| P880087/S014 1/22/10 | AcrySof® Intraocular Lenses | Alcon Research, Ltd. Tort Worth, TX 76134 | Change in the Bar-Sealer Monitoring System. |
| P890003/S180 1/15/10 | Prodigy Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Addition of a new weld system. |
| P890061/S017 1/12/10 | Accessory Model Number 0020 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P890061/S018 1/15/10 | Ventak P ICDs | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P910023/S228 1/22/10 | Epic HF, Epic + HF, Epic II HF, Epic II+ HF, Atlas HF, Atlas+ HF, Atlas II HF, Atlas II+ HF, Promote, and Promote + High Voltage Pulse Generators | St. Jude Medical, CRDM Sylmar, CA 91342 | Change in the process water system monitoring frequency and locations at Arecibo, Puerto Rico manufacturing facility. |
| P910073/S081 1/12/10 | ENDOTAK Reliance S, ENDOTAK Reliance, ENDOTAK Endurance EZ, ENDOTAK Reliance SG, ENDOTAK SQ Patch Lead, ENDOTAK Reliance G; Accessory Model Number: 6024, 6765 - 6772, 6824, 6825, 6833, 6927, 6931, 6946, 6952, 6971, and 6972 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P910073/S082 1/15/10 | Endotak ICDs | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P910077/S100 1/12/10 | Ventak Mini III/IV, ENDOTAK SQ Array Lead, and ENDOTAK SQ Array XP; Accessory Model Numbers: 0067, 0068, 6831, 6835, 6996, and 6998 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P910077/S101 1/15/10 | Ventak PRx and Ventak Mini I-IV ICDs | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P930014/S037 1/22/10 | AcrySof® Intraocular Lenses | Alcon Research, Ltd. Tort Worth, TX 76134 | Change in the Bar-Sealer Monitoring System. |
| P930035/S018 1/12/10 | Accessory Model Number 6942 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P930035/S019 1/15/10 | Ventak P2 ICDs | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P940008/S025 1/12/10 | Accessory Model Number 6623 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P940008/S026 1/15/10 | RES-Q / RES-Q Micron ICDs | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P950001/S020 1/12/10 | Selute Picotip Steroid Eluting Leads and Accessory Model Number: 6505 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P950001/S021 1/15/10 | Selute Leads | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P950009/S011 1/8/10 | BD FocalPoint Slide Profiler | BD Diagnostics Durham, NC 27703 | New vendor of a component programmed to control different aspects of the image processing. |
| P950022/S068 1/22/10 | Riata, Riata ST, Riata ST Optim, and Durata Leads | St. Jude Medical, CRDM Sylmar, CA 91342 | Change in the process water system monitoring frequency and locations at Arecibo, Puerto Rico manufacturing facility. |
| P960004/S044 1/12/10 | Thinline II Sterox/Ez, Fineline II Sterox/EZ; Accessory Model Numbers: 6032 - 6066, 6220, and 6221 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P960004/S045 1/15/10 | Thinline / Fineline Leads | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P960006/S025 1/12/10 | Sweet Picotip Rx, Sweet Tip Rx, Flextend and Accessory Model Number: 6616 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P960006/S026 1/15/10 | Sweet Tip Rx / Flextend Leads | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P960009/S074 1/13/10 | Activa® Therapy for DBS | Medtronic Neuromodulation Minneapolis, MN 55432 | Increasing the bake time for ceramic substrates prior to the solder prep reflow and adding an additional bake after the clean and dry processing step. |
| P960009/S076 1/21/10 | Activa PC Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Increase in the press force used to form the battery cathodes which will reduce the cathode thickness variation and increase the yield of the RX1 battery production. |
| P960011/S015 1/7/10 | BD 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 | Change in the layout of the manufacturing facility and relocation of the dissolution vessel and microfiltration system. |
| P960011/S016 1/7/10 | BD 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) | Ferring Pharmaceuticals, Inc. Parsippany, NJ 07054 | Change in a quality control test method for the finished device. |
| P960013/S056 1/22/10 | Tendril, Tendril ST, Tendril STS, and OptiSense Leads | St. Jude Medical, CRDM Sylmar, CA 91342 | Change in the process water system monitoring frequency and locations at Arecibo, Puerto Rico manufacturing facility. |
| P960030/S029 1/22/10 | Passive Plus, IsoFlex S, IsoFlex P, and IsoFlex Optim Leads | St. Jude Medical, CRDM Sylmar, CA 91342 | Change in the process water system monitoring frequency and locations at Arecibo, Puerto Rico manufacturing facility. |
| P960040/S212 1/12/10 | Ventak Prizm VR/DR, Ventak Prizm VR/HE, Ventak Prizm DR/HE, Ventak Prizm 2 VR/DR, Vitality VR, Vitality DR, Ventak Prizm AVT, Vitality AVT, Vitality DS, Vitality EL, Vitality DS/VR, Vitality 2 DR/ DR EL, Vitality 2 VR/VR EL, Vitality HE, Confient RF1 HE, Teligen HE VR, and Teligen HE DR | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| D970003/S115 1/12/10 | Insignia Entra SSI, Insignia Entra DDD, Insignia SSIR SC IS1 MV, Insignia Plus SSIR, Insignia Entra SSIR, Insignia DDDR DC IS1, Insignia DDDR DC 3.2, Insignia Entra DDDR, Insignia Plus DDDR. Nexus Entra SSI, Nexus Plus SSIR. Nexus Entra SSIR, Nexus Entra DDD, Nexus Entra DDDR, Altrua 20/40/60, and Nexus Plus DDDR | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P970004/S076 1/13/10 | Interstim Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Increasing the bake time for ceramic substrates prior to the solder prep reflow and adding an additional bake after the clean and dry processing step. |
| P970012/S060 1/6/10 | Kappa 400 DR and Kappa 400 SR IPGs | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P970012/S061 1/15/10 | Kappa 400 Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Addition of a new weld system. |
| P980016/S217 1/6/10 | GEM II, Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II DR/VR, Virtuoso IIDR/VR, and Secure DR/VR Family of ICDs | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P980018/S007 1/21/10 | HercepTest™ | Dako Denmark A/A Glostrup, Denmark | Changes in the Control Slides for the HercepTest™ kit. |
| P980035/S151 1/6/10 | Adapta, Sensia Versa, and Relia IPGs | Medtronic, Inc. Mounds View, MN 55112 | Addition of a second source supplier of substrate. |
| P980035/S152 1/6/10 | Kappa 600/700,650, 800/900, Reila, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta, Versa, and Sensia Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P980035/S154 1/15/10 | Adapta, Sensia, Versa, Relia Families of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Addition of a new weld system. |
| P990001/S059 1/6/10 | Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita 2 DDDR, C-Series, and T-Series Family of IPGs | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P000006/S018 1/15/10 | Titan Inflatable Penile Prosthesis | Coloplast Corp. Minneapolis, MN 55411 | Modification of the reservoir dip coating process using a new piece of equipment. |
| P000007/S023 1/14/10 | Edwards Prima Plus Stentless Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Addition of alternate material suppliers. |
| P000032/S031 1/7/10 | Her Option® Office Cryoablation Therapy System | American Medical Systems, Inc. Minnetonka, MN 55343 | Change in the final tester of the device to better monitor test results as well as changes in the test methods used in the final tester. |
| P010012/S229 1/12/10 | Cognis family of CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 | Additional header supplier. |
| P010012/S231 1/12/10 | Contak Renewal, Contak Renewal 3, Contak Renewal 3 HE, Conlak Renewal 3 RF, Contak Renewal 3 RF HE, Livian RF1 SE, Livian RF1 HE, Contak Renewal 3 AVT, Contak Renewal 3 AVT HE, Cognis, Easytrak 2/3, Easytrak 2/3 IS-1, Acuity Spiral; Accessory Model Numbers: 6002, 6003, 6004, 6005, 6007, 6100, 6628, 6741, 6742, 6743, 6773, and 6744 | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P010012/S232 1/15/10 | Contak CD, Easytrak, Livian, Cognis, Acuity Spiral CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P010013/S027 1/7/10 | NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 | Addition of an alternate supplier of component material. |
| P010015/S075 1/6/10 | InSync and InSync III Family of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P010031/S177 1/6/10 | InSync, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync in Protect, InSync Sentry, and InSync Maximo Family of ICDs; Concerto, Concerto II, Maximo II, and Consulta Family of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 | Relocation of an ethylene oxide sterilizer. |
| P010041/S022 1/14/10 | Carpentier-Edwards S.A.V. Bioprosthesis | Edwards Lifesciences LLC Irvine, CA 92614 | Addition of alternate material suppliers. |
| P020009/S057 1/29/10 | Express® / Express2® Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change in a manufacturing inspection procedure. |
| P020026/S072 1/6/10 | CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 | Change for the distal tip rounding operation. |
| P020026/S075 1/14/10 | CYPHER® Sirolimus-Eluting Coronary Stent on RAPTOR™ Over-the-Wire Delivery System and RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 | Change in the sterilization process for the device. |
| P020026/S077 1/21/10 | CYPHER® Sirolimus-eluting Coronary Stent on RAPTOR(t) Over-the-Wire Delivery System of RAPTORRAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 | Additional testing site for raw material testing. |
| P030005/S060 1/12/10 | Contak Renewal TR | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P030025/S081 1/29/10 | Taxus® Express2® Paclitaxel-eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change in a manufacturing inspection procedure. |
| P030035/S065 1/22/10 | Frontier, Frontier II, and Anthem Low Voltage Pulse Generators | St. Jude Medical, CRDM Sylmar, CA 91342 | Change in the process water system monitoring frequency and locations at Arecibo, Puerto Rico manufacturing facility. |
| P030054/S143 1/22/10 | Cadence, Cadet, Contour, Contour II/MD, Atlas II/MD, Profile II/MD, Photon, Photon Micro, Current, Current +, Atlas II, Atlas +, Epic II, Epic +, and Convert High Voltage Pulse Generators | St. Jude Medical, CRDM Sylmar, CA 91342 | Change in the process water system monitoring frequency and locations at Arecibo, Puerto Rico manufacturing facility. |
| P040004/S007 1/29/10 | ADVIA Centaur HBc Total Assay | Siemens Healthcare Diagnostics East Walpole, MA 02032 | Alternate supplier for a raw material used in a kit component used in the device. |
| P040014/S012 1/12/10 | Therapy Cardiac Ablation Catheter | St. Jude Medical Irvine, CA 92614 | Addition of a step prior to bonding the tip. |
| P040016/S048 1/29/10 | VeriFLEX™ (Liberté®) Bare Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change in a manufacturing inspection procedure. |
| P040020/S022 1/22/10 | AcrySof® Intraocular Lenses | Alcon Research, Ltd. Tort Worth, TX 76134 | Change in the Bar-Sealer Monitoring System. |
| P040042/S017 1/12/10 | Therapy Dual 8, Therapy and Safire TX Ablation Catheter | St. Jude Medical Irvine, CA 92614 | Addition of a step prior to bonding the tip. |
| P040044/S024 1/12/10 | Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 94043 | Change to manufacturing work instructions. |
| P040048/S011 1/11/10 | Trilogy AB Acetabular System | Zimmer, Inc. Warsaw, IN 46581 | Addition of an alternate test method for X-Ray Diffraction Determination (XRD) of Phase Content of the Plasma-Sprayed Hydroxyapatite coatings as well as addition of two new contract testing facilities (Lambda Technologies in Cincinnati, Ohio and Evans Analytical Group (EAG) in Round Rock, Texas). |
| P050012/S022 1/28/10 | DexCom Seven® Plus Continuous Glucose Monitoring System | DexCom, Inc. San Diego, CA 92121 | Change to Eight-Channel CalCheck quality control tool. |
| P050019/S002 1/12/10 | Carotid Wallstent™ Monorail™ Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 | Change to the batch release testing. |
| P050046/S005 1/12/10 | Acuity Steerable | Boston Scientific Corporation St. Paul, MN 55112 | Change in the biological indicator used for the sterilization process. |
| P050046/S006 1/15/10 | Acuity Steerable Leads | Boston Scientific Corporation St. Paul, MN 55112 | Addition of sterilization hoop racks. |
| P060008/S036 1/29/10 | Taxus® Liberté® Paclitaxel-eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Change in a manufacturing inspection procedure. |
| P060019/S010 1/12/10 | Therapy Cool Path Ablation Catheter | St. Jude Medical Irvine, CA 92614 | Addition of a step prior to bonding the tip. |
| P060033/S045 1/13/10 | Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Changes to the balloon subassembly manufacturing processes. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 67
Summary of PMA Originals Under Review
Total Under Review: 81
Total Active: 41
Total On Hold: 40
Number Greater Than 180 Days: 8
Summary of PMA Supplements Under Review
Total Under Review: 568
Total Active: 375
Total On Hold: 193
Number Greater Than 180 Days: 14
Summary of All PMA Submissions Received
Originals: 4
Supplements: 67
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 67
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 134.42
FDA Time: 97.48 Days MFR Time: 36.94 Days
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