The Food & Drug Administration released a list of pre-market approvals granted in May:
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P090028 5/11/11 |
VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Approval for the VITROS® Immunodiagnostic Products HBeAg Reagent Pack, Calibrator and Controls. This device is indicated for: VITROS® Immunodiagnostic Products HBeAg Reagent Pack – For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the VITROS® ECi/ECiQ Immunodiagnostic System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. VITROS® Immunodiagnostic Products HBeAG Calibrator – For use in the calibration of the VITROS® ECi/ECiQ Immunodiagnostic Systems for the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection. VITROS® Immunodiagnostic Products HBeAg Controls – For use in monitoring the performance of the VITROS® ECi/ECiQ Immunodiagnostic Systems when used for the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection when using the VITROS® Immunodiagnostic Products HBe-Ag Reagent Pack. |
P100013 5/19/11 |
EXOSEAL Vascular Closure Device | Cordis Corporation Bridgewater, NJ 08807 |
Approval for the EXOSEAL Vascular Closure Device. This device is indicated as follows: The EXOSEAL Vascular Closure Device (VCD) is indicated for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization procedures using a standard 5F, 6F, or 7F vascular sheath introducer with up to 12 cm working length. Additionally, the EXOSEAL VCD is indicated to reduce times to hemostasis and ambulation in patients who have undergone interventional catheterization procedures, using a standard 6F vascular sheath introducer up to a 12 cm working length, who have received preprocedural and/or intraprocedural glycoprotein (GP) IIb/IIIa inhibitor therapy. |
P100014 5/27/11 |
Solesta® | Oceana Therapeutics, Inc. Edison, NJ 08817 |
Approval for the Solesta®. This device is indicated for the treatment of fecal incontinence in patients 18 years and older who have failed conservative therapy (e.g., diet, fiber therapy, anti-motility medications). |
P100017 5/17/11 |
Abbott RealTime HCV, Abbott RealTime HCV Amplification Reagent Kit, Abbott RealTime HCV Control Kit, Abbott RealTime HCV Calibrator Kit, and optional UNG Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval of Abbott RealTime HCV, Abbott RealTime HCV Amplification Reagent Kit, Abbott RealTime HCV Control Kit, Abbott RealTime HCV Calibrator Kit, and optional UNG Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV. This device is indicated for: Abbott RealTime HCV Amplification Reagent Kit – The Abbott Real Time HCV assay is an in vitro reverse transcription- polymerase chain reaction (RT-PCR) assay for use with the Abbott mSample Preparation System reagents and with the Abbott m2000sp and m2000ry4 instruments for the quantitation of hepatitis C viral (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. Specimens containing HCV genotypes 1-6 have been validated for quantitation in the assay. The Abbott RealTime HCV assay is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non- sustained virological response to HCV therapy. The results from the RealTime HCV assay must be interpreted within the context of all relevant clinical and laboratory findings. Assay performance characteristics have been established for individuals treated with peginterferon alfa-2a or 2b plus ribavirin. No information is available on the assay’s predictive value when other therapies are used. Assay performance for determining the state of HCV infection has not been established. The Abbott RealTime HCV assay is not for screening blood, plasma, serum or tissue donors for HCV, or to be used as a diagnostic test to confirm the presence of HCV infection. Abbott RealTime HCV Control Kit – The Abbott RealTime HCV controls are used to establish run validity of the Abbott RealTime HCV assay when used for the quantitation of Hepatitis C Virus (HCV) RNA in human serum and plasma (EDTA) from HCV infected individuals. Abbott RealTime HCV Calibrator Kit – The Abbott RealTime HCV Calibrators are for calibration of the Abbott RealTime HCV assay when used for the quantitative determination of Hepatitis C Virus (HCV) RNA in human serum and plasma (EDTV) for HCV infected individuals. Uracil-N-Glycosylase (UNG) for use in conjunction with Abbott RealTime HCV – This kit is to be used in conjunction with Abbott RealTime HCV, List No. In30-90, as an optional contamination control for customer laboratories that are currently using or have previously used amplification technologies that incorporate uracil into the amplification product. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
D970003/S128 5/17/11 Real-Time |
Latitude Patient Management System | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01. |
P790002/S026 5/19/11 180-Day |
Biomet® EBI Bone Healing System | EBI, L.L.C. Parsippany, NJ 07054 |
Approval for a modified, redesigned, noninvasive Pulsed Electromagnetic Field bone growth stimulator system that uses new SFLX coils. |
P790005/S047 5/6/11 Special |
OrthoGen OsteoGen Implantable Bone Growth Stimulator | EBI, L.P. Parsippany, NJ 07054 |
Approval for manufacturing changes involving the verification of alcohol sterility and the magnet overriding test fixture. |
P820003/S104 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P820060/S026 5/20/11 180-Day |
AxSYM AFP | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois. |
P840001/S182 5/6/11 135-Day |
Synergy® IPG, Synergy Versitrel® IPG, RestorePrime® Implantable Neurostimulator (INS), PrimeAdvanced® INS, Restore® INS, RestoreUltra® INS and RestoreAdvanced® INS Model Families | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the addition of an optional deburring process. |
P840064/S044 5/27/11 135-Day |
DISCOVISC®, DUOVISC® and VISCOAT® Ophthalmic Viscosurgical Devices | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for the addition of a third packaging line for the DISCOVISC®, DUOVISC® and VISCOAT® Ophthalmic Viscosurgical Devices. |
P840068/S048 5/17/11 Real-Time |
Latitude Patient Management System | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01. |
P850051/S074 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P860003/S059 5/13/11 Real-Time |
THERAKOS CELLEX™ Photopheresis System – Procedural Kit | THERAKOS, Inc. Raritan, NJ 08869 |
Approval for a minor dimensional change to a Y-adaptor in the CELLEX™ Procedural Kit and a change in the splice bond Bushing of the CELLEX™ Procedural Kit’s anticoagulant (green) line. |
P860004/S149 5/6/11 135-Day |
SynchroMed Pump | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the addition of an optional deburring process. |
P880086/S183 5/11/11 180-Day |
AddVent, Affinity, Identity, Verity, Integrity, Victory, Zephyr, Accent, Trilogy, Synchrony, Paragon and Phoenix Family of Pacemakers/CRT-Ps | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P880086/S199 5/10/11 135-Day |
Accent, Identity, Identity ADx, Verity ADx, Victory, Zephyr and Microny CRT-Ps | St. Jude Medical – CRMD Sunnyvale, CA 94086 |
Approval for tighter screening limits and the inclusion of a reflow thermal conditioning during the manufacture of tantalum capacitor components. |
P890003/S209 5/4/11 180-Day |
Application Software for Reveal ICM/Patient Assistant, Carelink Home Monitor and CardioSight Monitor | Medtronic, Inc. Mounds View, MN 55112 | Approval for updates to Medtronic’s Reveal 2090 Application Software Model SW007 for use with the Medtronic Reveal Implantable Cardiac Monitor (ICM) System. |
P890003/S211 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P890003/S220 5/27/11 Real-Time |
CareLink Monitor, Revo MRI SureScan Pacing System | Medtronic, Inc. Mounds View, MN 55112 |
Approval for Model 2490G (version 9V5) Medtronic CareLink Monitor and Model 2491 Device Data Management Application (Revo MRI SW018 XMLTU and EnRhythm MRI V7.3 SW005 XMLTU). |
P890047/S032 5/27/11 |
PROVISC® Ophthalmic Viscosurgical Device | Alcon Research, Ltd. Fort Worth, TX 76134 |
Approval for the addition of a third packaging line for the DISCOVISC®, DUOVISC® and VISCOAT® Ophthalmic Viscosurgical Devices. |
P890055/S032 5/10/11 Real-Time |
MedStream Programmable Infusion System | Codman & Shurtleff, Incorporated Raynam, MA 02767 |
Approval for a new adhesive to secure the antenna and modification to the piezo actuator release specification. The device, as modified, will be marketed under the trade name MedStream Programmable Infusion System and is indicated for the chronic intrathecal infusion of baclofen injection sterile solution (5.0 pH to 7.0 pH) in the treatment of severe spasticity. |
P890055/S033 5/23/11 Real-Time |
MedStream Programmable Infusion System | Codman & Shurtleff, Incorporated Raynham, MA 02767 |
Approval for software modification to the MedStream Programmable Infusion System. The modified MedStream Pump will have software PS-100044 version 3.06, the modified Control Unit will have software PS-100046 version 3.00. PS-100045 version 3.04, PS-1000047 version 3.09 and PS-100021 version 2.00. The device, as modified, will be marketed under the trade name MedStream Programmable Infusion System and is indicated for the chronic intrathecal infusion of baclofen injection sterile solution (5.0 pH to 7.0pI I) in the treatment of severe spasticity. |
P900061/S098 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P910007/S022 5/20/11 180-Day |
AxSYM Total PSA | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois. |
P910023/S227 5/11/11 180-Day |
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 Families of ICDs/ CRT-Ds | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P910023/S258 5/10/11 135-Day |
Atlas II, Atlas+, Epic+, Epic II, Epic II+, Current RF Current +, Current Accel and Fortify ICDs | St. Jude Medical – CRMD Sunnyvale, CA 94086 |
Approval for tighter screening limits and the inclusion of a reflow thermal conditioning during the manufacture of tantalum capacitor components. |
P910077/S111 5/17/11 Real-Time |
Latitude Patient Management System | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01. |
P920015/S056 5/13/11 180-Day |
Subcutaneous Lead System and Transvene SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Center Villalba in Villalba, Puerto Rico. |
P930014/S045 5/3/11 Panel-Track |
ACRYSOF® Toric Posterior Chamber Intraocular Lens and AcrySOF® IQ Toric Posterior Chamber Intraocular Lens | Alcon Research Ltd. Fort Worth, TX 76134 | Approval for the ACRYSOF® Toric Posterior Chamber Intraocular Lens Models SN60T6, SN60T7, SN60T8, and SN60T9 and AcrySOF® IQ Toric Posterior Chamber Intraocular Lens Models SN6AT6, SN6AT7, SN6AT8 and SN6AT9. This device is indicated for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision. |
P930022/S012 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P940031/S070 5/17/11 Real-Time |
Latitude Patient Management System | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01. |
P950022/S067 5/11/11 180-Day |
Riata, Riata ST, Riata ST Optim and Durata Family of Leads | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P950037/S096 5/26/11 Real-Time |
Implantable Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs. |
P960006/S029 5/19/11 135-Day |
Transvenous Bipolar Pacing Lead | Boston Scientific – CRM St. Paul, MN 55112 |
Approval for a change to laser welding equipment used in the manufacture of pacing leads. |
P960009/S112 5/6/11 135-Day |
Kinetra® INS, Activa® PC INS, Activa® SC INS, Activa® RC INS Model Families | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the addition of an optional deburring process. |
P960013/S055 5/11/11 180-Day |
Tendril, Tendril ST, Tendril STS and OptiSense Family of Leads | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P960030/S028 5/11/11 180-Day |
Passive Plus, IsoFlex S, IsoFlex P and IsoFlex Optim Family of Leads | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P960040/S242 5/17/11 Real-Time |
Latitude Patient Management System | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01. |
P970004/S109 5/6/11 135-Day |
InterStim® II INS | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the addition of an optional deburring process. |
P970012/S081 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P970027/S011 5/20/11 180-Day |
AxSYM Anti-HCV | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois. |
P980007/S014 5/20/11 180-Day |
AxSYM Free PSA | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois. |
P980016/S273 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P980016/S295 5/26/11 Real-Time |
Protecta, Protecta XT | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families. |
P980023/S044 5/26/11 Real-Time |
Drug-eluting Permanent Pacemaker/ Defibrillator Electrodes | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs. |
P980035/S200 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P980035/S209 5/19/11 135-Day |
Adapta/Relia/Sensia/ Versa Families of Implantable Pulse Generators | Medtronic, Inc. Mounds View, MN 55112 |
Approval for update of the EEPROM serial number. |
P980035/S219 5/26/11 Real-Time |
Advisa | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families. |
P980050/S043 5/13/11 180-Day |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Center Villalba in Villalba, Puerto Rico. |
P980050/S057 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P990001/S082 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P990004/S017 5/31/11 Real-Time |
Surgifoam® Hemostatic Matrix Kit | Ethicon, Inc. Somerville, NJ 08876 |
Approval for changes to the reconstitution of method for the thrombin component and modified the method of mixing with the powdered gelatin component. |
P990004/S019 5/17/11 180-Day |
SURGIFLO® Hemostatic Matrix and SURGIFLO® Hemostatic Matrix Kit with Thrombin | Ethicon, Inc. Somerville, NJ 08876 |
Approval for the introduction of a new Hemostatic Matrix formulation, redesign of the application components, reorganization of the packaging, and addition of EVITHROM lyophilized thrombin labeling directly into the directions for use as well as other updated labeling changes. |
P000009/S045 5/26/11 Real-Time |
Single and Dual Chamber ICD | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs. |
P000012/S026 5/24/11 135-Day |
COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, version 2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for eliminating aurintricarboxylic acid (ATA) activity testing in COBAS AmpliPrep/ COBAS AMPLICOR HCV Internal Control Buffer and Specimen Diluent bulk solutions. |
P010012/S265 5/17/11 Real-Time |
Latitude Patient Management System | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01. |
P010014/S029 5/3/11 135-Day |
Oxford® Partial Knee Twin Peg Femoral Components | Biomet, Inc. Warsaw, IN 46581 |
Approval for additional manufacturing steps for the Oxford® Partial Knee Twin Peg Femoral components. |
P010015/S107 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P010015/S119 5/26/11 Real-Time |
Consulta CRT-P, Syncra CRT-P Module | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families. |
P010019/S022 5/18/11 135-Day |
CIBA VISION (lotrafilcon B) Soft Contact Lenses | CIBA VISION Corporation Duluth, GA 30097 |
Approval to change the plasma coating parameters. |
P010031/S228 5/13/11 180-Day |
Medtronic CareLink Programmer | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Medtronic Model 9986 Desktop/ BOSS Version 2.4 for use on the Medtronic Model 2090 CareLink Programmer. |
P010031/S249 5/26/11 Real-Time |
Protecta, Protecta XT | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families. |
P010033/S017 5/26/11 Special |
QuantiFERON® TB-Gold In-Tube | Cellestis, Incorporated Valencia, CA 91355 |
Approval for revisions to the device package insert and marketing booklet subsequent to the publication of the CDC’s Updated Guidelinesfor Using Interferon Gamma Release Assays to Detect Mycobacterium tuberculosis Infection – United States, 2010, in accordance with the original PMA post-approval requirement. |
P010050/S012 5/12/11 Real-Time |
IMMULITE 2000® XPi HBsAg | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for introduction of a new instrument model, the IMMULITE 2000® XPi Analyzer, as a new family member of the currently approved IMMULITE 2000® Analyzer, to be used with the currently approved IMMULITE 2000® HBsAG assay. The device, as modified, will be marketed under the trade name IMMULITE 2000® HBsAG assay an is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information. |
P010051/S008 5/12/11 Real-Time |
IMMULITE 2000® XPi Anti HBc | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for introduction of a new instrument model, the IMMULITE 2000® XPi Analyzer, as a new family member of the currently approved IMMULITE 2000® Analyzer, to be used with the currently approved IMMULITE 2000® Anti-HBc assay. The device, as modified, will be marketed under the trade name IMMULITE 2000® XPi Anti-HBce assay an is indicated for in vitro diagnostic use for the laboratory diagnosis of acute and chronic hepatitis b virus infections in conjunction with other serological and clinical information. |
P010052/S008 5/12/11 Real-Time |
IMMULITE 2000® Anti-HBs | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for introduction of a new instrument model, the IMMULITE 2000® XPi Analyzer, as a new family member of the currently approved IMMULITE 2000® Analyzer, to be used with the currently approved IMMULITE2000® Anti-HBs assay. The device, as modified, will be marketed under the trade IMMULITE 2000® XPi Anti-HBs assay and is indicated for in vitro diagnostic use for the detection of anti-HBs and is indicative of laboratory diagnosis of seroconversion from hepatitis b virus (hbv) infection. |
P010053/S007 5/12/11 Real-Time |
IMMULITE 2000® XPi Anti-HBc IgM | Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for introduction of a new instrument model, the IMMULITE 2000® XPi Analyzer, as a new family member of the currently approved IMMULITE 2000® Analyzer, to be used with the currently approved IMMULITE 2000® Anti-HBc IgM assay. The device, as modified, will be marketed under the trade name IMMULITE 2000® XPi Anti-HBc IgM assay and is indicated for in vitro diagnostic use for the laboratory diagnosis of acute or recent (usually within 6 months) hepatitis b virus infections in conjunction with other serological and clinical information. |
P020026/S059 5/27/11 180-Day |
CYPHER® Sirolimus-Eluting Coronary Stent on the RAPTOR™ Over-the-Wire Delivery System or RAPTRORAIL® Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 | Approval for the XTEND manufacturing process and an extension of your approved shelf life from 3 to 6 months. |
P020026/S083 5/27/11 Real-Time |
CYPHER® Sirolimus-Eluting Coronary Stent System | Cordis Corporation Miami Lakes, FL 33014 |
Approval for updated Magnetic Resonance Imaging (MRI) compatibility testing and MRI conditions of use labeling. |
P020047/S032 5/19/11 135-Day |
Multi-Link Vision, Multi-Link Mini-Vision OTW and RX, Multi-Link 8™, Multi-Link 8 LL™, Multi-Link 8 SV™ Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92590 |
Approval to remove a redundant verification step for a spiral mandrel used in the stent manufacturing process. |
P030005/S073 5/17/11 Real-Time |
Latitude Patient Management System | Boston Scientific CRM St. Paul, MN 55112 |
Approval for an update to the Model 2909 System Software v8.01 and the addition of Model 2905 PDF Report Generator v1.01. |
P030006/S024 5/13/11 180-Day |
Prolieve Thermodilation System | Boston Scientific Corporation Marlborough, MA 01752 |
Approval of the post-approval study protocol. |
P030016/S019 5/5/11 180-Day |
Visian ICL | Star Surgical Monrovia, CA 91016 |
Approval of the post-approval study protocol. |
P030017/S118 5/9/11 Real-time |
Precision® Spinal Cord Stimulation (SCS) System | Boston Scientific Neuromodulation Corporation Valencia, CA 91355 |
Approval for a change in the outer box used as secondary packaging for lead and extensions. |
P030035/S064 5/11/11 180-Day |
Frontier, Frontier II, Aescula and Anthem Family of Pacemakers/ CRT-Ps | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC located in Arecibo, Puerto Rico. |
P030035/S079 5/10/11 135-Day |
Anthem and Frontier II Pacemakers | St. Jude Medical – CRMD Sunnyvale, CA 94086 |
Approval for tighter screening limits and the inclusion of a reflow thermal conditioning during the manufacture of tantalum capacitor components. |
P030036/S022 5/5/11 180-Day |
AS Anchoring Sleeve Kit | Medtronic, Inc. Mounds View, MN 55112 |
Approval for manufacturing site located at Medtronic Puerto Rico Operations Company (MPROC) in Villabla, Puerto Rico. |
P030052/S006 5/26/11 Special |
UroVysion Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines, IL 60018 |
Approval for a labeling change to the UroVysion Bladder Cancer Kit package insert to correct an inaccuracy in a labeling schematic in the UroVysion Package Insert 30-608358 identified during a review of the package insert. |
P030054/S142 5/11/11 180-Day |
Epic HF, Epic+ HF, Epic II HF, Epic II+ HF, Atlas HF, Atlas+ HF, Atlas II HF, Atlas+ HF, Atlas+ II HF Family of ICDs/CRT-Ds, Promote, Promote+ Families of ICDs/CRT-Ds, QuickSite, QuickFlex | St. Jude Medical Sylmar, CA 91342 |
Approval for a manufacturing site at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P030054/S182 5/11/11 Real-Time |
CRT Leads | St. Jude Medical Sylmar, CA 91342 |
Approval for a dimensional change to the IS-1 connector front seal. |
P030054/S183 5/10/11 135-Day |
Atlas +HF, Epic HF, Epic +HF, Promote RF, Promote +, Promote Accel and Unify CRT-Ds | St. Jude Medical – CRMD Sunnyvale, CA 94086 |
Approval for tighter screening limits and the inclusion of a reflow thermal conditioning during the manufacture of tantalum capacitor components. |
P040001/S019 5/4/11 Real-Time |
X-STOP Interspinous Spacer System | Medtronic Spine, LLC Sunnyvale, CA 94089 |
Approval for implementation of new instrument cleaning and sterilization processes and is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis (with X-Ray, MRI, and/or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing). The X-STOP® Spacer is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/ buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X-STOP Spacer may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels. |
P040002/S031 5/6/11 180-Day |
AFX Endovascular AAA System | Endologix, Inc. Irvine, CA 92618 |
Approval for a new ePTFE graft process as well as changes to the delivery system. |
P040012/S034 5/6/11 Panel-Track |
RX Acculink Carotid Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval for the RX Acculink Carotid Stent System. The device is indicated for high surgical risk and standard surgical risk patients as follows: High Surgical Risk – Th RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular’s Accunet or Emboshield family of Embolic Protection Systems (EPS), is indicated for the treatment of revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and ≥ 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and ≥ 80% stenosis of the common or internal carotid artery by ultrasound or angiogram; and patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. Standard Surgical Risk – Th RX Acculink Carotid Stent System, used in conjunction with the Accunet Embolic Protection System (EPS), is indicated for the treatment of patients at standard risk for adverse events from cartoid endarterectomy who require carotid revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram OR patients without neurological symptoms and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram; and patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion. |
P040013/S016 5/27/11 180-Day |
GEM 21S® | Luitpold Pharmaceuticals, Incorporated Norristown, PA 19403 |
Approval for a change in the rh-PDGF-BB syringe cap material, made by Becton Dickinson, the cap supplier, from West 1883 to Helovet FM27, based on a change in Becton Dickinson rubber raw materials suppliers. |
P050012/S033 5/19/11 135-Day |
Dexcom™ SEVEN® and seven plus® Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Approval for a proposed change to eliminate redundant post-winding and post-second-parylene visual inspection for the sensor component of the SEVEN® and SEVEN PLUS® Continuous Glucose Monitoring System. |
P050020/S032 5/16/11 180-Day |
FreeStyle Navigator® Continuous Glucose Monitoring System | Abbott Laboratories Alameda, CA 94502 |
Approval for changes to the Quality System drawings of ten Receiver and Transmitter components, used for First Article Inspection activities prior to release for manufacturing. |
P050023/S045 5/26/11 Real-Time |
Pulse Generator, Pacemaker Implantable with Cardiac Resynchronization | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs. |
P050047/S014 5/11/11 135-Day |
Juvéderm Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Approval for the removal of an in- process quality control test used in the manufacture of Juvéderm Hyaluronate Gel Implants. |
P050049/S005 5/20/11 180-Day |
AxSYM HBsAg/ Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois. |
P060003/S007 5/20/11 180-Day |
AxSYM AUSAB | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois. |
P060003/S009 5/13/11 135-Day |
ABBOTT AxSYM AUSAB | Abbott Laboratories Abbott Park, IL 60064 | Approval for modifications to the quality control test methods. |
P060008/S070 5/24/11 180-Day |
TAXUS Liberte Paclitaxel Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval of the post- approval study protocol. |
P060009/S003 5/20/11 180-Day |
AxSYM CORE-M | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois. |
P060012/S005 5/20/11 180-Day |
AxSYM CORE | Abbott Laboratories Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Laboratories in North Chicago, Illinois. |
P060030/S018 5/5/11 Special |
COBAS® AmpliPrep/COBAS TaqMan® HCV Test | Roche Molecular Systems, Inc. Pleasanton, CA 94588 | Approval for an addition to the COBAS® AmpliPrep/COBAS TaqMan® HCV Test v1.0 Package Insert. |
P060035/S005 5/20/11 135-Day |
ARCHITECT CORE-M | Abbott Laboratories Abbott Park, IL 60064 |
Approval for changes to manufacturing methods and process changes. |
P070005/S002 5/5/11 180-Day |
REPEL-CV Bioresorbable Adhesion Barrier | Synthemed Corporation Iselin, NJ 08830 |
Approval of the post-approval study protocol. |
P070008/S023 5/26/11 Real-Time |
Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for an additional supplier for a second source of silicones for use in injection molded parts for leads and accessories, and sealing plugs in PGs and ICDs. |
P070015/S036 5/23/11 180-Day |
XIENCE V® Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Approval for updates to your labeling to include 1-year results from the SPIRIT IV trial, a pooled SPIRIT II-III-IV analysis, gender-specific analyses, and updated results from the SPIRIT FIRST, II, and III trials. |
P070015/S054 5/24/11 Panel-Track |
XIENCE nano™ Everolimus Eluting Coronary Stent System and PROMUS™ Everolimus Eluting Coronary Stent System | Abbott Vascular Santa Clara, CA 95054 |
Approval to expand the product matrix to include the 2.25 mm XIENCE™ V Everolimus Eluting Coronary Stem System. This device size will be marketed under the trade name XIENCE nano™ Everolimus Eluting Coronary Stem System and will also be distributed as the PROMUS ™ Everolimus Eluting Coronary Stent System. The addition of the 2.25 mm XIENCE nano™ Everolimus Eluting Coronary Stent System will expand the originally approved indications to include treatment of coronary artery lesions with reference vessel diameters >2.25 mm to <2.50 mm. Therefore, the XIENCE™ V Everolimus Eluting Coronary Stent System is now indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length < 28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. |
P070015/S060 5/19/11 135-Day |
XIENCE V® and Promus® Everolimus Eluting Coronary Stent Systems | Abbott Vascular, Inc. Temecula, CA 92590 |
Approval to remove a redundant verification step for a spiral mandrel used in the stent manufacturing process. |
P070022/S008 5/5/11 135-Day |
Adiana Permanent Contraception System | Hologic, Inc. Marlborough, MA 01752 |
Approval for revision of written work instructions for a soldering operation. |
P070022/S019 5/27/11 180-Day |
Adiana Permanent Contraception System |
Hologic, Inc. Marlborough, MA 01752 |
Approval of a backup sterilization facility located at Biotest Laboratories, Inc., in Brooklyn Park, Minnesota. |
P080013/S006 5/20/11 180-Day |
DuraSeal Xact Sealant System | Covidien Bedford, MA 01801 |
Approval of the post-approval study protocol. |
P080023/S005 5/20/11 135-Day |
ARCHITECT CORE | Abbott Laboratories Abbott Park, IL 60064 |
Approval for changes to manufacturing methods and process changes. |
P080025/S001 5/6/11 135-Day |
InterStim® II INS | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for addition of an optional deburring process. |
P090013/S012 5/27/11 Real-Time |
Revo MRI SureScan Pacing System | Medtronic, Inc. Mounds View, MN 55112 |
Approval for Software application SW005 version 7.3 for CareLink Model 2090 Programmer. |
P090013/S013 5/27/11 Real-Time |
CareLink Monitor, Revo MRI SureScan Pacing System | Medtronic, Inc. Mounds View, MN 55112 |
Approval for Model 2490G (version 9V5) Medtronic CareLink Monitor and Model 2491 Device Data Management Application (Revo MRI SW018 XMLTU and EnRhythm MRI V7.3 SW005 XMLTU). |
P090013/S019 5/26/11 Real-Time |
Revo MRI | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the design changes of the X7R-0805 (XC291), NPO-0805 (XC177), NPO-1206 (XC308), X7R-0603 (XC251), NPO-0603 (XC259), X5R-0402 (XC263) Multilayer Ceramic Capacitor Families. |
P090018/S001 5/6/11 180-Day |
Esteem® | Envoy Medical Corporation Saint Paul, MN 55110 |
Approval for the lead design (Model 7004/7504 leads) and lead manufacturing site change (Envoy Medical Corp., St. Paul, Minnesota). |
P100010/S007 5/23/11 Real-Time |
Arctic Front® Cardiac Cryoablation Catheter | Medtronic Cryo-Cath LP Eagan, MN 55123 |
Approval for changes in the leak detection circuit and blood sensor board. |
P100021/S002 5/9/11 180-Day |
Endurant Stent Graft System | Medtronic, Inc. Santa Rosa, CA 95403 |
Approval of the post-approval study protocol. |
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/S055 5/20/11 |
VISTAKON (etafilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Use an automated Device History Record Checklist. |
P780007/S045 5/13/11 |
Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses | Cooper Vision Incorporated Pleasanton, CA 94588 |
Utilize the dye penetration test method for testing package integrity. |
P820003/S105 5/19/11 |
EPG Safety Cable | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P820060/S029 5/12/11 |
Abbott AxSYM AFP | Abbott Laboratories Abbott Park, IL 60064 |
Change the specifications for in- process testing and customer release testing for AxSYM AFP as a result of an internal review of the product relative to updated specification setting procedures. |
P830061/S063 5/19/11 |
Capsure, Vitatron Crystaline, Vitatron Excellence+ and Vitatron Excellence PS+ | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P840001/S183 5/4/11 |
RestorePrime® Implantable Neurostimulator (INS), PrimeAdvanced® INS, Restore® INS, RestoreUltra® INS, RestoreAdvanced® INS, Itrel® 3 INS, Synergy® INS and Synergy Versitrel INS Model Families | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation of newly validated process parameters for the blister sealing machine at Medtronic Puerto Rico Operations Company (MPROC) located in Juncos, Puerto Rico. |
P840064/S046 5/18/11 |
VISCOAT Ophthalmic Viscosurgical Device, DISCOVISC Opthalmic Viscosurgical and DUOVISC Viscoelastic System | Alcon Research, Ltd. Fort Worth, Texas 76134 |
Expand the electronic batch record system to include electronic documentation of the reactor/vessel cleaning for ophthalmic viscosurgical devices. |
P850089/S076 5/19/11 |
CapSure, CapSure Z Novus, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse and Vitatron Impulse II | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P860057/S078 5/5/11 |
Carpentier-Edwards® PERIMOUNT® Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a third- party supplier of the molded silicone inserts used in the devices. |
P870056/S043 5/5/11 |
Carpentier-Edwards® Porcine Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a third- party supplier of the molded silicone inserts used in the devices. |
P870077/S039 5/5/11 |
Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a third- party supplier of the molded silicone inserts used in the devices. |
P880086/S201 5/3/11 |
Family of CRT-Ps | St. Jude Medical Sunnyvale, CA 94086 |
Alternate plating supplier. |
P890003/S221 5/19/11 |
CapSure, CapSure Model, Prodigy and Pacemaker Repair Kit | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P890047/S034 5/18/11 |
PROVIS Ophthalmic Viscosurgical Device | Alcon Research, Ltd. Fort Worth, Texas 76134 |
Expand the electronic batch record system to include electronic documentation of the reactor/vessel cleaning for ophthalmic viscosurgical devices. |
P900061/S101 5/12/11 |
Transvene Epicardial Lead | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test. |
P900061/S102 5/19/11 |
Upsizing Sleeve, ACE, ACE 5434T, ACE Header and Lead End Pin Cap | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P910007/S028 5/11/11 |
Abbott ARCHITECT Total PSA | Abbott Laboratories Abbott Park, IL 60064 |
Addition of a quality control test method and addition of an alternate manufacturing material (polypropylene resin) and an alternate vendor. |
P910023/S260 5/5/11 |
Cadence Family of ICDs | St. Jude Medical Sylmar, CA 91342 |
Addition of a secondary supplier for organic substrates. |
P910023/S261 5/3/11 |
Family of ICDs | St. Jude Medical Sunnyvale, CA 94086 |
Alternate plating supplier. |
P910023/S262 5/11/11 |
Family of ICDs | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Change in the MEMS sensor mounting material. |
P910054/S005 5/17/11 |
Toray Inoue Balloon Catheter | Toray Industries ( America), Inc. New York, NY 10017 |
Addition of a sterilizer at your Seta plant facility. |
P910073/S093 5/3/11 |
Reliance Leads | Boston Scientific Corporation St. Paul, MN 55112 |
Replace the existing automated optical measuring system with a new system. |
P920015/S075 5/12/11 |
Y Adaptor, Subcutaneous Lead, Transvene SVC Lead and Tunneling Lead | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test. |
P920015/S076 5/19/11 |
“Y” Adaptor/ Extender Kit, DF-1 Connector Port Pin Plug, Lead Adaptor, Sprint, Sprint Quattro, Sprint Quattro Lead, Subcutaneous Lead and Transvene SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P930029/S029 5/19/11 |
Cath RF Conductor, Conductr 5 Mn 8 fr, Conductr RF MC, Contactr Catheter, RF Conductr MC, RF Enhancr II, RF Marinr UNI, RF Marinr MC 5/5/5, RF Marinr MC 7F 112 cm, RF Marinr MC 2-5-2, RF Marinr MC UN 110 cm, RF Marinr MC XL 5/5/5, RF Marinr MC XL 7 fr, RF Marinr SC 5F, RF Marinr SC XL 5fr, RF Marinr SC XS 5fr, RF Marinr SCXL 5F, and RF Marinr SCXXL 5F |
Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P930039/S051 5/18/11 |
CapSure Fix Novus and Vitatron Leads | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a second supplier for titanium nitride coated electrode components. |
P930039/S052 5/19/11 |
CapSure, SureFix, Vitatron Crystalline ActFix, and Vitatron Pirouet S+ | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P950024/S030 5/12/11 |
CapSure EPI Unipolar Lead and CapSure EPI Bipolar Lead | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test. |
P950024/S031 5/19/11 |
CapSure Epicardial Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P950037/S095 5/6/11 |
Evia, Entovis, Estella, Effecta and Ecuro Family of Pacemakers | Biotronik, Inc. Lake Oswego, OR 97035 |
Addition of an inspection step during the battery manufacturing process. |
P960009/S114 5/4/11 |
Soletra® INS, Kinetra® INS, Activa® PC INS, Activa SC INS and Activa RC INS Model Families | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation of newly validated process parameters for the blister sealing machine at Medtronic Puerto Rico Operations Company (MPROC) located in Juncos, Puerto Rico. |
P960030/S033 5/5/11 |
IsoFlex Low Voltage Leads | St. Jude Medical – CRMD Sylmar, CA 91342 |
Alternate supplier for the inner and outer coils used to manufacture low voltage leads. |
P970003/S126 5/20/11 |
VNS Therapy® System | Cyberonics, Inc. Houston, TX 77058 |
Addition of a thread gauging process to the header attachment process and the modification or final inspection process. |
P970004/S110 5/4/11 |
InterStim® Neurostimulator and InterStim II Neurostimulator | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation of newly validated process parameters for the blister sealing machine at Medtronic Puerto Rico Operations Company (MPROC) located in Juncos, Puerto Rico. |
P970004/S111 5/6/11 |
InterStim II Implantable Neurostimulator | Medtronic, Inc. Minneapolis, MN 55432 |
Change in the testing equipment and test specifications. |
P970012/S084 5/26/11 |
Kappa 400 DR IPG and Kappa 400 SR IPG | Medtronic, Inc. Mounds View, MN 55112 |
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging. |
P970020/S063 5/12/11 |
Zeta RX, Ultra RX, and Ultra OTW Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
A manual to an automated process change for packaging labeling inspection. |
P970021/S035 5/5/1 |
GYNECARE THERMACHOICE III Uterine Balloon Therapy System | ETHICON, Inc. Somerville, NJ 08876 |
Change in raw material and supplier. |
P980007/S019 5/11/11 |
Abbott ARCHITECT Free PSA | Abbott Laboratories Abbott Park, IL 60064 |
Addition of a quality control test method and addition of an alternate manufacturing material (polypropylene resin) and an alternate vendor. |
P980016/S289 5/5/11 |
Protecta DR, VR, XT DR, and XT VR Model Families | Medtronic, Inc. Mounds View, MN 55112 |
The subject devices are able to be manufactured using new plating lines at the qualified supplier. |
P980016/S290 5/5/11 |
Protecta DR/VR and Protecta XL DR/VR Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Moving sterilization equipment within a facility and implementation of a barcode reader system. |
P980016/S291 5/5/11 |
Protecta DR/VR and Protecta XT DR/VR Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Multiple manufacturing changes to the assembly line, equipment improvement and parameters, process monitoring, and laboratory analysis. |
P980016/S292 5/5/11 |
Protecta DR/VR, Protecta XT DR/VR | Medtronic, Inc. Mounds View, MN 55112 |
Change to an epoxy dispenser parameter, the implementation of a software revision for a laser bonder, and an update to the sterile packaging operation process. |
P980016/S293 5/13/11 |
Protecta DR/VR and Protecta XT DR/VR Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Multiple changes including a component supplier and inspection change, changes to an in-process device tester, and a change to an inspection test method. |
P980016/S294 5/13/11 |
Protecta DR/VR and Protecta XT DR/VR Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Multiple manufacturing changes including a component test method update, implementation of a new component cleaning process, and implementation of additional labeling equipment and software. |
P980016/S296 5/23/11 |
Protecta DR, Protecta VR, Protecta XT DR and Protecta XT VR | Medtronic, Inc. Mounds View, MN 55112 |
Alignment of process software versions. |
P980016/S297 5/19/11 |
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta XT/Protecta ICD, Secura and Virtuoso II | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P980016/S299 5/26/11 |
SecuraDR/VR lCD, Virtuoso II DR/VR, Maximo II DR/VR, Entrust lCD, Virtuoso lCD, Protecta DR, Protecta VR, Protecta XT DR, Protecta – XT VR, InSync II Marquis lCD, InSync III Marquis lCD, InSync Marquis lCD, InSync Sentry ICD family, and InSync Maximo ICD family. |
Medtronic, Inc. Mounds View, MN 55112 |
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging. |
P980022/S097 5/20/11 |
Medtronic Paradigm Continuous Glucose Monitoring Systems | Medtronic, Inc. Northridge, CA 91325 |
Inclusion of an alternate supplier for the case assembly used in the manufacture of the Paradigm REAL-Time and Paradigm REAL-Time Revel Insulin Pumps. |
P980035/S213 5/5/11 |
Advisa DR | Medtronic, Inc. Mounds View, MN 55112 |
The subject devices are able to be manufactured using new plating lines at the qualified supplier. |
P980035/S214 5/5/11 |
Advisa DR IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Moving sterilization equipment within a facility and implementation of a barcode reader system. |
P980035/S215 5/5/11 |
Advisa DR | Medtronic, Inc. Mounds View, MN 55112 |
Change to an epoxy dispenser parameter, the implementation of a software revision for a laser bonder, and an update to the sterile packaging operation process. |
P980035/S216 5/13/11 |
Advisa DR IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Multiple manufacturing changes including a component test method update, implementation of a new component cleaning process, and implementation of additional labeling equipment and software. |
P980035/S217 5/18/11 |
EnRhythm IPG and Advisa IPG | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the cleaning process performed on hybrid components. |
P980035/S218 5/19/11 |
EnRhythm IPG | Medtronic, Inc. Mounds View, MN 55112 |
Process standardization for selected cleaning operations. |
P980035/S220 5/23/11 |
Advisa DR | Medtronic, Inc. Mounds View, MN 55112 |
Alignment of process software versions. |
P980035/S221 5/19/11 |
350 Series, Adapta, Advisa, EnRhythm, Relia, Sensia, Sigma and Versa | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P980035/S222 5/26/11 |
AdaptalVersa/Sensia IPG family, Relia IPG, EnRhythm IPG, Advisa DR IPG, Kappa 700,800/900 IPG family, Sigma IPG family, Medtronic 350 IPG series, EnPulse lPG, and AT500 Systems |
Medtronic, Inc. Mounds View, MN 55112 |
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging. |
P980050/S060 5/12/11 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test. |
P980050/S061 5/19/11 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P990001/S087 5/19/11 |
Vitatron DA+ C-Series and Vitatron DA+ T-Series | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P990001/S088 5/26/11 |
Dema IPG (includes Clarity DOOR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita 2, and Vita 2 DOOR), C-series lPG, and T-series IPG |
Medtronic, Inc. Mounds View, MN 55112 |
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging. |
P990009/S032 5/10/11 |
Floseal Hemostatic Matrix | Baxter Healthcare Corporation McGaw Park, IL 60085 |
Change in an in-process test method for the device. |
P990012/S008 5/4/11 |
Elecsys HBsAG Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Change to increase production capacity for a component common to all devices. |
P990013/S031 5/4/11 |
STAAR Surgical Collamer Intraocular Lenses | STAAR Surgical Company Monrovia, CA 91016 |
Modification to the blocking process for the manufacture of the product lines. |
P990023/S011 5/18/11 |
CELLUGEL Opthalmic Viscosurgical Device | Alcon Research, Ltd. Fort Worth, Texas 76134 |
Expand the electronic batch record system to include electronic documentation of the reactor/vessel cleaning for ophthalmic viscosurgical devices. |
P990056/S012 5/24/11 |
Elecsys Total PSA Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46520 |
Change in manufacturing site from buildings 351/352 to building 761, all within the Roche Penzberg, Germany facility for production of a component (biotinylated- and ruthenium-labeled antibodies or “conjugated antibodies”) used in this assay. |
P000006/S023 5/25/11 |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Manufacturing contractor change of a component. |
P000027/S010 5/24/11 |
Elecsys Free PSA Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46520 |
Change in manufacturing site from buildings 351/352 to building 761, all within the Roche Penzberg, Germany facility for production of a component (biotinylated- and ruthenium-labeled antibodies or “conjugated antibodies”) used in this assay. |
P000044/S026 5/11/11 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack & Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change in the process of preparing antifoam solution and the storage conditions of prepared antifoam solution. |
P010013/S035 5/10/11 |
NovaSure Impedance Controlled Endometrial Ablation System | Hologic, Inc. Marlborough, MA 01752 |
Relocation of a cable assembly process. |
P010015/S113 5/5/11 |
Syncra CRT-P and Consulta CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
The subject devices are able to be manufactured using new plating lines at the qualified supplier. |
P010015/S114 5/5/11 |
Consulta and Syncra Families of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Moving sterilization equipment within a facility and implementation of a bar code reader system. |
P010015/S115 5/5/11 |
Consulta CRT-P, Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Change to an epoxy dispenser parameter, the implementation of a software revision for a laser bonder, and an update to the sterile packaging operation process. |
P010015/S116 5/13/11 |
Consulta and Syncra Families of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Multiple changes including a component supplier and inspection change, changes to an in-process device tester, and a change to an inspection test method. |
P010015/S117 5/13/11 |
Consulta and Syncra Families of CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Multiple manufacturing changes including a component test method update, implementation of a new component cleaning process, and implementation of additional labeling equipment and software. |
P010015/S118 5/18/11 |
Consulta CRT-P and Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the cleaning process performed on hybrid components. |
P010015/S120 5/23/11 |
Consulta CRT-P and Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Alignment of process software versions. |
P010015/S121 5/19/11 |
Attain, Consulta CRT-P, InSync III and Syncra CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P010019/S023 5/11/11 |
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear | CIBA VISION Corporation Duluth, GA 30097 |
Raw material test method change. |
P010019/S024 5/18/11 |
Lotrafilcon B Soft Contact Lenses | CIBA VISION Corporation Duluth, GA 30097 |
Change in the Secondary Packaging Side Laser Printing Inspection System. |
P010031/S243 5/5/11 |
Protecta CRT-D and XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
The subject devices are able to be manufactured using new plating lines at the qualified supplier. |
P010031/S244 5/5/11 |
Protecta and Protecta XL Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Moving sterilization equipment within a facility and implementation of a barcode reader system. |
P010031/S245 5/5/11 |
Protecta and Protecta XT Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Multiple manufacturing changes to the assembly line, equipment improvement and parameters, process monitoring, and laboratory analysis. |
P010031/S246 5/5/11 |
Protecta CRT-D, Protecta XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Change to an epoxy dispenser parameter, the implementation of a software revision for a laser bonder, and an update to the sterile packaging operation process. |
P010031/S247 5/13/11 |
Protecta and Protecta XT Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Multiple changes including a component supplier and inspection change, changes to an in-process device tester, and a change to an inspection test method. |
P010031/S248 5/13/11 |
Protecta and Protecta XT Families of CRT-Ds | Medtronic, Inc. Mounds View, MN 55112 |
Multiple manufacturing changes including a component test method update, implementation of a new component cleaning process, and implementation of additional labeling equipment and software. |
P010031/S250 5/23/11 |
Protecta CRT-D and Protecta XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Alignment of process software versions. |
P010031/S251 5/19/11 |
Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II and Protecta/Protecta XT | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P010031/S253 5/26/11 |
InSync Sentry CRT-D, Concerto lCD, Consulta CRT-D, Concerto II CRT-D, Maximo II CRT-D, Protecta CRT-D, and Protecta XT CRT-D. | Medtronic, Inc. Mounds View, MN 55112 |
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging. |
P010041/S027 5/5/11 |
Carpentier-Edwards® Supraanular (S.A.V.(R)) Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a third- party supplier of the molded silicone inserts used in the devices. |
P010054/S013 5/4/11 |
Elecsys Anti-HBs Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Change to increase production capacity for a component common to all devices. |
P020009/S073 5/4/11 |
Express and Express 2 Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Automation of the packaging and verification process. |
P020018/S038 5/17/11 |
Zenith AAA Endovascular Graft | Cook Incorporated Bloomington, IN 47404 |
Alternate supplier of graft material. |
P020047/S034 5/12/11 |
VISION RX, VISION OTW, Mini VISION RX, Mini VISION OTW, and Multi Link 8 RX Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
A manual to an automated process change for packaging labeling inspection. |
P030005/S075 5/5/11 |
Contak Renewal TR | Boston Scientific Corporation CRM St. Paul, MN 55112 |
Revise the electrical test software. |
P030009/S055 5/12/11 |
Driver & Micro Driver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Reduction in pyrogen testing sample size. |
P030016/S020 5/4/11 |
STAAR Surgical Implantable Collamer Lenses for Myopia | STAAR Surgical Company Monrovia, CA 91016 |
Modification to the blocking process for the manufacture of the product lines. |
P030022/S018 5/26/11 |
REFLECTION Ceramic Acetabular Hip System | Smith & Nephew, Inc. Memphis, TN 38116 |
Use of an alternative manufacturing supplier. |
P030024/S015 5/11/11 |
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and VITROS Immunodiagnostic Products Anti-HBc Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Manufacturing changes being made to the device. |
P030035/S081 5/3/11 |
Family of Pacemakers | St. Jude Medical Sunnyvale, CA 94086 |
Alternate plating supplier. |
P030036/S028 5/12/11 |
Anchoring Sleeve Kit | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including a process recipe change, new tray configurations, and the addition of a monitoring test. |
P030036/S029 5/18/11 |
SelectSecure 4 French Leads | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a second supplier for titanium nitride coated electrode components. |
P030036/S030 5/19/11 |
SelectSecure | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P030054/S185 5/5/11 |
Epic HF/Atlas+ HF Family of CRT-Ds | St. Jude Medical Sylmar, CA 91342 |
Addition of a secondary supplier for organic substrates. |
P030054/S186 5/3/11 |
Family of CRT-Ds | St. Jude Medical Sunnyvale, CA 94086 |
Alternate plating supplier. |
P030054/S187 5/11/11 |
Family of CRT-Ds | St. Jude Medical, Inc. Sunnyvale, CA 94086 |
Change in the MEMS sensor mounting material. |
P040016/S071 5/4/11 |
VeriFLEX (Liberte) Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Automation of the packaging and verification process. |
P040045/S018 5/20/11 |
VISTAKON (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Use an automated Device History Record Checklist. |
P040050/S008 5/27/11 |
Macroplastique Implants | Uroplasty, Inc. Minnetonka, MN 55343 |
Implementation of a new heat sealing instrument for final package manufacturing. |
P050018/S014 5/12/11 |
AngioSculpt® PTCA Scoring Balloon Catheter, Rapid Exchange (RX) | AngioScore, Inc. Fremont, CA 94538 |
Manufacturing change to include a new part number for the device and the purchase of the OEM rapid exchange balloon catheter manufactured by a qualified supplier. |
P050019/S007 5/2/11 |
Carotid WALLSTENT® Monorail® Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Several equipment upgrades, a change to the physical line layout, and introduction of automated process settings. |
P050023/S044 5/6/11 |
Lumax Family of ICDs and CRT-Ds | Biotronik, Inc. Lake Oswego, OR 97035 |
Addition of an inspection step during the battery manufacturing process. |
P050042/S011 5/13/11 |
ARCHITECT Anti- HCV | Abbott Laboratories Abbott Park, IL 60064 |
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices. |
P050051/S011 5/13/11 |
ARCHITECT AUSAB | Abbott Laboratories Abbott Park, IL 60064 |
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices. |
P060001/S012 5/26/11 |
Protégé GPS & Protégé Carotid Stent System | Ev3, Inc. Plymouth, MN 55441 |
Optimize the ultrasonic cleaning time used in the manufacture of the device. |
P060001/S013 5/17/11 |
Protégé GPS & Protégé RX Carotid Stent System | Ev3, Inc. Plymouth, MN 55441 |
Changes in the electropolishing preparation cleaning process. |
P060006/S020 5/4/11 |
Express SD Renal Monorail Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Automation of the packaging and verification process. |
P060007/S013 5/13/11 |
ARCHITECT HBsAg/ Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices. |
P060008/S069 5/4/11 |
TAXUS Liberte Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Automation of the packaging and verification process. |
P060033/S065 5/12/11 |
Endeavor Spring Zotarolimus-Eluting Coronary Stent | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Reduction in pyrogen testing sample size. |
P060035/S007 5/13/11 |
ARCHITECT CORE-M | Abbott Laboratories Abbott Park, IL 60064 |
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices. |
P060039/S025 5/19/11 |
Attain StarFix | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P070006/S005 5/4/11 |
T-SPOT® .TB Test | Oxford Immunotec, Ltd. Oxfordshire, UK OX14 4RY |
Addition of a second approved supplier of antibody coated plates for the device. |
P070015/S067 5/4/11 |
XIENCE V & PROMUS Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
Change to annual certification testing for an approved supplier. |
P070015/S068 5/12/11 |
XIENCE V & PROMUS Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
Changes to the test method for the identification and assay of antioxidant in the acceptance and stability testing of the everolimus drug substance. |
P070015/S069 5/12/11 |
XIENCE V Everolimus Eluting Coronary Stent System and PROMUS Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
A manual to an automated process change for packaging labeling inspection. |
P070022/S018 5/10/11 |
Adiana Permanent Contraception System | Hologic, Inc. Marlborough, MA 01752 |
The move of manufacturing lines. |
P080006/S022 5/5/11 |
Attain Ability Plus | Medtronic, Inc. Mounds View, MN 55112 |
Change in aeration cycle time. |
P080006/S023 5/18/11 |
Attain Ability LV Lead, Attain Ability Plus LV Lead and Attain Ability Straight LV Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a second supplier for titanium nitride coated electrode components. |
P080006/S024 5/23/11 |
Attain Ability Plus and Attain Ability Straight | Medtronic, Inc. Mounds View, MN 55112 |
Alignment of process software versions. |
P080006/S025 5/19/11 |
Attain Ability, Attain Ability Plus and Attain Ability Straight | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P080023/S007 5/13/11 |
ARCHITECT CORE | Abbott Laboratories Abbott Park, IL 60064 |
Change to add a quality control test method for a component accessory common to all devices, and a change to add an alternate supplier of a manufacturing material common to all devices. |
P080025/S002 5/4/11 |
InterStim® Neurostimulator and InterStim II Neurostimulator | Medtronic, Inc. Minneapolis, MN 55432 |
Implementation of newly validated process parameters for the blister sealing machine at Medtronic Puerto Rico Operations Company (MPROC) located in Juncos, Puerto Rico. |
P080025/S003 5/6/11 |
InterStim II Implantable Neurostimulator | Medtronic, Inc. Minneapolis, MN 55432 |
Change in the testing equipment and test specifications. |
P080027/S006 5/4/11 |
OraQuick® HCV Rapid Antibody Test | OraSure Technologies, Inc. Bethlehem, PA 18015 |
Automate the vial filling and capping process for the Developer Solution Vials, a component in the device. |
P090003/S011 5/31/11 |
Express LD Iliac Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of a new sterilization chamber. |
P090006/S006 5/17/11 |
Complete SE Vascular Stent System | Medtronic Vascular Santa Rosa, CA 95403 |
Extension of the scope of several activities conducted as a third party storage location. |
P090007/S002 5/4/11 |
Elecsys Anti-HCV Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Change to increase production capacity for a component common to all devices. |
P090008/S002 5/4/11 |
Elecsys Anti-HCV Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Change to increase production capacity for a component common to all devices. |
P090009/S002 5/4/11 |
Elecsys Anti-HCV Immunoassay | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Change to increase production capacity for a component common to all devices. |
P090013/S015 5/5/11 |
Revo MRI | Medtronic, Inc. Mounds View, MN 55112 |
The subject devices are able to be manufactured using new plating lines at the qualified supplier. |
P090013/S016 5/18/11 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Changes to the cleaning process performed on hybrid components. |
P090013/S017 5/19/11 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Process standardization for selected cleaning operations. |
P090013/S018 5/18/11 |
CapSure Fix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Addition of a second supplier for titanium nitride coated electrode components. |
P090013/S020 5/19/11 |
Revo MRI | Medtronic, Inc. Mounds View, MN 55112 |
Use of MES web services; replacing the paper logs with electronic data logs; and a modification of the default lot size in new work orders. |
P090013/S021 5/26/11 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Update to Process Operation Descriptions and the implementation of new test monitoring for packaging. |
P090013/S022 5/26/11 |
Revo MRI SureScan Pacing System | Medtronic, Inc. Mounds View, MN 55112 |
Relocation of a sterilizer system within and existing location. |
P100021/S008 5/17/11 |
Endurant Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Extension of the scope of several activities conducted as a third party storage location. |
P100029/S001 5/16/11 |
Trifecta Valve | St. Jude Medical, Inc. St. Paul, MN 55117 |
Addition of abattoirs for bovine tissue sourcing. |
P100040/S001 5/2/11 |
Valiant Thoratic Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Addition of lubricant to a manufacturing process. |
P100040/S002 5/17/11 |
Valiant Thoracic Stent Graft with Captiva Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Extension of the scope of several activities conducted as a third party storage location. |
P100040/S003 5/25/11 |
Valiant Thoracic Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Transfer of post sterilization inspections to an alternate site. |
P100040/S004 5/17/11 |
Valiant Thoracic Stent Graft with Captiva Delivery System | Medtronic Vascular Santa Rosa, CA 95403 |
Extension of the scope of several activities conducted as a third party storage location. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 109
Summary of PMA Originals Under Review
Total Under Review: 95
Total Active: 44
Total On Hold: 51
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 645
Total Active: 455
Total On Hold: 190
Number Greater Than 180 Days: 11
Summary of All PMA Submissions Received
Originals: 2
Supplements: 95
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 109
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 153
FDA Time: 116.7 Days MFR Time: 36.3 Days