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PMA Final Decisions for March 2013

Fri, 05/24/2013 - 12:00am
U.S. Food & Drug Administration

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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P100030
3/1/13
ArterX Surgical Sealant Tenaxis Medical, Inc.
Mountain View, CA
94043
Approval for the ArterX Surgical Sealant.  This device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P840001/S219
3/19/13
180-Day
Medtronic SureScan™ MRI Implantable Neurostimulation System Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for of the Medtronic SureScanTM MRI Implantable Neurostimulation System, which consists of the PrimeAdvanced SureScan™ MRI IPG Model 97702; RestoreUltra SureScan™ MRI IPG Model 97712; RestoreAdvanced SureScan™ MRI IPG Model 97713; RestoreSensor SureScan™ MRI IPG Model 97714; Vectris SureScanTM MRI 1x8 Subcompact Leads Models 977A160, 977A175, and 977A190; Vectris SureScanTM MRI 1x8 Compact Leads Models 977A260, 977A275, and 977A290; Vectris 1x8 Subcompact Trialing Lead Model 977D160; Vectris 1x8 Compact Trialing Lead Model 977D260; Patient Programmer Model 97740; Patient Recharger Kit Model 97754; N'Vision Application Card, version AAP01 Model 8870; Clinician Programmer Model 8840; External Antenna Model 37092; External Neurostimulator Model 37022; and External Neurostimulator Model 37021. The device, as modified, will be marketed under the trade name Medtronic SureScan™ MRI Implantable Neurostimulation System and is indicated as follows. The Medtronic SureScan MRI Implantable Neurostimulation System is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: 1) Failed Back Syndrome or Low Back Syndrome or Failed Back; 2) Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome; 3) Post Lammectomy Pain; 4) Unsuccessful Disk Surgery; 5) Degenerative Disk Disease (DDD)/ Herniated Disk pain refractory to conservative and surgical interventions; 6)Peripheral Causalgia; 7) Epidural Fibrosis; 8) Arachnoiditis or Lumbar Adhesive Arachnoiditis; 9) Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and 10) Multiple Back Operations.
P850048/S032
3/26/13
Real-Time
Access Hybritech PSA reagents on the Access Immunoassay System Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the change in polypropylene resin used for the reaction vessel container material that is used as the container for the reaction in the determination of results for Access AFP Reagents, Access Hybritech PSA Reagents, Access Hybritech free PSA Reagents and Access Hybritech p2PSA Reagents; 2) the change in polypropylene resin used for the reagent pack container for Access Hybritech p2PSA Reagents; and 3) the change in polypropylene resin used for the bottle cap for Access AFP Sample Diluent and Access Hybritech PSA Sample Diluent and Access Substrate for Access AFP, Access Hybritech PSA, Access Hybritech free PSA and Access Hybritech p2PSA.
P860004/S180
3/4/13
Real-Time
Synchromed II Drug Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for a modification to the Synchromed II battery capacity specification.
P860057/S104
3/12/13
Special
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
P870056/S057
3/12/13
Special
Carpentier-Edwards Porcine Aortic and Mitral Bioprosthesis Edwards Lifesciences LLC
Irvine, CA
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
P870077/S052
3/12/13
Special
Carpentier-Edwards and Duraflex Low Pressure Porcine Mitral Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
P890003/S254
3/13/13
180-Day
CareLink Encore™ Programmer for Reveal Medtronic, Inc.
Mounds View, MN
55112
Approval for the CareLink Encore™ Programmer 2090 for Reveal.
P950005/S037
3/7/13
180-Day
Celsius Diagnostic/ Ablation Deflectable Tip Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval of modifications to the STOCKERT 70 Radiofrequency Generator for Cardiac Ablation and CoolFLOW® Irrigation Pump as an integrated system.
P950029/S073
3/12/13
Real-Time
Reply and Esprit Family of Pacemakers Sorin CRM
Arvada, CO
80004
Approval for an alternate feedthrough component.
P950029/S075
3/13/13
Special
Reply and Esprit Family of Pacemakers Sorin CRM
Arvada, CO
80004
Approval for reinforcement of an existing 100% in-process screening step intended to be applied for a limited quantity of three (3) identified lots.
P950032/S071
3/14/13
Real-Time
Apligraf (Graftskin) Organogenesis, Inc.
Canton, MA
02021
Approval for the introduction of Human Epidermal Keratinocyte cell strain 157 (HEP 157) for use in the manufacture of Apligraf.
P950037/S116
3/18/13
180-Day
Ilesto 7/5 VR-T ICD, Ilesto 7/5
VR-T DX ICD, Ilesto 7/5 DR-T ICD, Ilesto 7/5 HFT CRT-D; Iforia 7/5 VR-T ICD, Iforia
7/5 VR-T DX ICD, Iforia 7/5 DR-T ICD, Iforia 7/5
HF-T CRT-D; and the PSW 1205.U
Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Ilesto 7/5 VR-T ICD, Ilesto 7/5 VR-T DX ICD, Ilesto 7/5 DR-T ICD, Ilesto 7/5 HFT CRT-D; Iforia 7/5 VR-T ICD, Iforia 7/5 VR-T DX ICD, Iforia 7/5 DR-T ICD, Iforia 7/5 HF-T CRT-D; and the PSW 1205.U.
P950037/S119
3/25/13
Real-Time
CardioMessenger II and CardioMessenger
II-S Updates
Biotronik, Inc.
Lake Oswego, OR
97035
Approval for updated GSM and landline modems, updated firmware versions, and updates to the device labeling.
P960058/S100
3/12/13
180-Day
HiResolution Bionic Ear System, HiResOptima Sound Processing Strategy Advanced Bionics, LLC
Sylmar, CA
91342
Approval for the HiRes Optima Sound Processing Strategy.  HiRes Optima is a modification of the HiRes Fidelity 120 strategy, and is intended to optimize power efficiency. This new strategy improves battery life without compromising the listening benefits of the HiResolution Bionic Ear System.
D970003/S140
3/12/13
180-Day
Ingenio and
Advantio Pacemakers
Boston Scientific Corporation
St. Paul, MN
55112
Approval for the Ingenio Models K172, K173, K174; and Advantio Models K62, K63, and K64.
P970004/S146
3/27/13
135-Day
Sacral Nerve Stimulation (SNS), Urinary Implantable Neurostimulator (INS) Interstim Family Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for an update to the battery burn-in process and inspection methods.
P970038/S021
3/26/13
Real-Time
Access Hybritech Free PSA reagents on the Access Immunoassay System Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the change in polypropylene resin used for the reaction vessel container material that is used as the container for the reaction in the determination of results for Access AFP Reagents, Access Hybritech PSA Reagents, Access Hybritech free PSA Reagents and Access Hybritech p2PSA Reagents; 2) the change in polypropylene resin used for the reagent pack container for Access Hybritech p2PSA Reagents; and 3) the change in polypropylene resin used for the bottle cap for Access AFP Sample Diluent and Access Hybritech PSA Sample Diluent and Access Substrate for Access AFP, Access Hybritech PSA, Access Hybritech free PSA and Access Hybritech p2PSA.
P970051/S100
3/13/13
135-Day
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Approval for the introduction of a crimp pull tester.
P970051/S101
3/13/13
135-Day
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Approval for the introduction of a vacuum pickup tool.
P970051/S103
3/21/13
Real-Time
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Approval for te Sterile Silicone Template (SST) as a single use surgical tool to help check the size of the periosteal pocket, the shape and depth of the implant well, and appropriate positions for tie-down holes during the implant surgical procedure.
P980016/S357
3/26/13
180-Day
EnTrust ICD, and
Protecta DF4 ICD, Protecta lCD,
Protecta XT DF4 ICD, Protecta ICD, Secura DF4
ICD, Secura ICD, Virtuoso ICD and Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN
55112
Approval for labeling updates to incorporate the results of the RESPECT post- approval study final report, and additional labeling updates.
P980016/S360
3/18/13
135-Day
Maximo II, Protecta, Protecta XT, Secura, Virtuoso, and Virtuoso II DR/VR ICD’s Medtronic, Inc.
Mounds View, MN
55112
Approval for a change to the interface used with the final functional testing equipment.
P980016/S366
3/13/13
180-Day
Virtuoso II, Maximo II, Secura DF4, Secura, Entrust, Virtuoso Medtronic, Inc.
Mounds View, MN
55112
Approval for the Virtuoso II, Maximo II, Secura DF4, Secura, Entrust, Virtuoso.
P980022/S126
3/20/13
135-Day
Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time System, iPro Professional Continuous Glucose (CGM) Monitoring System and iPro2 Professional Continuous Glucose (CGM) Monitoring System Medtronic MiniMed
Northridge, CA
91325
Approval for the removal of the in-process refrigeration storage requirement throughout the fabrication and assembly of the sensors.
P980022/S131
3/22/13
Real-Time
iPro2 Professional Continuous Glucose Monitoring (CGM) System Medtronic MiniMed Northridge, CA
91325
Approval for the addition of a zero-ohm resistor to the iPro2 Recorder (MMT-7741) circuit board. The iPro2 Recorder is a component of the iPro2 Professional Continuous Glucose Monitoring (CGM) System.
P980035/S272
3/26/13
180-Day
Advisa DR Implantable Pulse Generator (lPG) DDDRP
Pacing System IPG
Medtronic, Inc.
Mounds View, MN
55112
Approval for labeling updates to incorporate the results of the RESPECT post- approval study final report, and additional labeling updates.
P980035/S280
3/13/13
180-Day
Kappa, Adapta, Sensia, Relia, Enpulse, Enrhythm, Advisa, Versa and Sigma Medtronic, Inc.
Mounds View, MN
55112
Approval for the Kappa 600, Kappa 650, Kappa 700, Kappa 800, Kappa 900, Adapta, Sensia, Relia, Enpulse, Enrhythm, Advisa, Versa and Sigma.
P980041/S022
3/26/13
Real-Time
Access AFP reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the change in polypropylene resin used for the reaction vessel container material that is used as the container for the reaction in the determination of results for Access AFP Reagents, Access Hybritech PSA Reagents, Access Hybritech free PSA Reagents and Access Hybritech p2PSA Reagents; 2) the change in polypropylene resin used for the reagent pack container for Access Hybritech p2PSA Reagents; and 3) the change in polypropylene resin used for the bottle cap for Access AFP Sample Diluent and Access Hybritech PSA Sample Diluent and Access Substrate for Access AFP, Access Hybritech PSA, Access Hybritech free PSA and Access Hybritech p2PSA.
P980049/S080
3/26/13
Real-Time
Orchestra/Orchestra Plus Programmer Software Update Sorin CRM
Arvada, CO
80004
Approval for updates to the Orchestra/Orchestra Plus Programmer Software applications that are used to interrogate and program the Paradym and Paradym RF family of ICDs and CRT-D devices.
P990001/S105
3/13/13
180-Day
Vitatron Desktop Software Application Medtronic, Inc.
Mounds View, MN
55112
Approval for the Vitatron Desktop Software Application, C60 DR, C20 SR and T60 DR.
P990002/S002
3/21/13
180-Day
FemSoft Urethral Insert Rochester Medical Corporation
Stewartville, MN  55976
Approval for labeling modifications.
P990025/S031
3/7/13
180-day
Navistar Diagnostic/ Ablation Deflectable Tip Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval of modifications to the STOCKERT 70 Radiofrequency Generator for Cardiac Ablation and CoolFLOW® Irrigation Pump as an integrated system.
P990071/S017
3/7/13
180-Day
Stockert 70 Radiofrequency Generator Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval of modifications to the STOCKERT 70 Radiofrequency Generator for Cardiac Ablation and CoolFLOW® Irrigation Pump as an integrated system.
P990081/S015
3/20/13
Real-Time
PATHWAY Anti-HER-2/neu Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for a change from fluorinated bottles to non-fluorinated bottles for storage of the general purpose reagents used in the staining with the PATHWAY and anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody.
P000007/S039
3/12/13
Special
Edwards Prima Plus Stentless Porcine Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
P000009/S051
3/18/13
180-Day
Ilesto 7/5 VR-T ICD, Ilesto 7/5
VR-T DX ICD, Ilesto 7/5 DR-T ICD, Ilesto 7/5 HFT CRT-D; Iforia 7/5 VR-T ICD, Iforia
7/5 VR-T DX ICD, Iforia 7/5 DR-T ICD, Iforia 7/5
HF-T CRT-D; and the PSW 1205.U
Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Ilesto 7/5 VR-T ICD, Ilesto 7/5 VR-T DX ICD, Ilesto 7/5 DR-T ICD, Ilesto 7/5 HFT CRT-D; Iforia 7/5 VR-T ICD, Iforia 7/5 VR-T DX ICD, Iforia 7/5 DR-T ICD, Iforia 7/5 HF-T CRT-D; and the PSW 1205.U.
P010012/S319
3/8/13
180-Day
ACUITY™ Spiral Leads Guidant Corporation
St. Paul, MN
55112
Approval of post-approval study protocol.
P010015/S166
3/13/13
180-Day
Insync III, Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
Approval for  the Insync III, Consulta CRT-P, Syncra CRT-P.
P010031/S310
3/26/13
180-Day
Concerto Implantable Cardioverter Defibrillator (ICD), Concerto II
Cardiac Resynchronization Therapy Defibrillator
(CRT-D), Consulta,
Consulta ICD, Protecta CRT-D, Protecta DF4
CRT-D, Protecta XT CRT-D, Protecta XT DR ICD and Protecta XT DF4 CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Approval for labeling updates to incorporate the results of the RESPECT post- approval study final report, and additional labeling updates.
P010031/S313
3/18/13
135-Day
Concerto and Consulta ICD’s, and Concerto II, Maximo II, Protecta, and Protecta XT CRT-D’s Medtronic, Inc.
Mounds View, MN
55112
Approval for a change to the interface used with the final functional testing equipment.
P010031/S319
3/13/13
180-Day
Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Maximo II DF4, Insync III Protect, Insync II Protect, Concerto Medtronic, Inc.
Mounds View, MN
55112
Approval for the Concerto II CRT-D, Consulta CRT-D, Maximo II CRT-D, Maximo II DF4, Insync III Protect, Insync II Protect, Concerto.
P010032/S066
3/15/13
Real-Time
Eon Mini Implantable Pulse Generator (IPG) St. Jude Medical
Plano, Texas
75024
Approval for design changes to the header of Eon Mini Implantable Pulse Generator (IPG), Model 3788.
P010041/S041
3/12/13
Special
Carpentier-Edwards S.A.V. Aortic Porcine Bioprosthesis Edwards Lifesciences LLC
Irvine, CA
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
P010068/S027
3/7/13
180-Day
Navistar® and Celsius® DS Diagnostic/Ablation Deflectable Tip Catheters Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval of modifications to the STOCKERT70 Radiofrequency Generator for Cardiac Ablation and CoolFLOW® Irrigation Pump as an integrated system.
P020055/S005
3/20/13
Real-Time
PATHWAY anti-C-kit Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for a change from fluorinated bottles to non-fluorinated bottles for storage of the aqueous general purpose reagents used in the staining with the PATHWAY Anti-C-KIT (9.7)  Rabbit Monoclonal Primary Antibody.
P030005/S088
3/12/13
180-Day
Invive Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Approval for the Invive Models V172, V173.
P030031/S041
3/7/13
180-Day
Navistar®
thermocool® Diagnostic/Ablation Catheter and Celsius® thermocool®
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval of modifications to the STOCKERT 70 Radiofrequency Generator for Cardiac Ablation and CoolFLOW® Irrigation Pump as an integrated system.
P040036/S030
3/7/13
180-Day
Navistar®
thermocool® Diagnostic/Ablation Catheter
Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval of modifications to the STOCKERT 70 Radiofrequency Generator for Cardiac Ablation and CoolFLOW® Irrigation Pump as an integrated system.
P050012/S050
3/11/13
135-Day
Dexcom SEVEN® PLUS Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA
92121
Approval for a modification of the transmitter text application method from machine engraving to laser marking.
P050016/S009
3/22/13
Real-Time
Cormet Hip Resurfacing System Corin USA, Limited
Tampa, FL
33607
Approval for the reprocessing of unused Cormet Resurfacing Heads that are approaching their expiration date.  The unused Cormet Resurfacing Heads will be opened from the packaging, cleaned, repacked, re-sterilized and relabeled with a 5 year shelf life.
P050023/S058
3/18/13
180-Day
Ilesto 7/5 VR-T ICD, Ilesto 7/5
VR-T DX ICD, Ilesto 7/5 DR-T ICD, Ilesto 7/5 HFT CRT-D; Iforia 7/5 VR-T ICD, Iforia
7/5 VR-T DX ICD, Iforia 7/5 DR-T ICD, Iforia 7/5
HF-T CRT-D; and the PSW 1205.U
Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Ilesto 7/5 VR-T ICD, Ilesto 7/5 VR-T DX ICD, Ilesto 7/5 DR-T ICD, Ilesto 7/5 HFT CRT-D; Iforia 7/5 VR-T ICD, Iforia 7/5 VR-T DX ICD, Iforia 7/5 DR-T ICD, Iforia 7/5 HF-T CRT-D; and the PSW 1205.U.
P050023/S061
3/25/13
Real-Time
CardioMessenger II and CardioMessenger    II-S Updates Biotronik, Inc.
Lake Oswego, OR
97035
Approval for updated GSM and landline modems, updated firmware versions, and updates to the device labeling.
P050047/S030
3/11/13
Real-Time
Juvederm® Ultra XC and Juvederm® Plus XC Allergan
Goleta, CA
93117
Approval for an extension of the shelf-life from 18 months to 20 months for the 1 mL syringe; an increase in the monoethylglycinexylidide (MEGX) impurity specification from 2.5% to 3.5% w/w of the label strength and total impurities from 3.0% to 4.3% of label strength.
P060027/S048
3/26/13
Real-Time
Orchestra/Orchestra Plus Programmer Software Update Sorin CRM
Arvada, CO
80004
Approval for updates to the Orchestra/Orchestra Plus Programmer Software applications that are used to interrogate and program the Paradym and Paradym RF family of ICDs and CRT-D devices.
P060037/S020
3/28/13
135-Day
NexGen LPS-Flex and LPS-Mobile Bearing Knees Zimmer, Inc.
Warsaw, IN
46581
Approval for changes to automate the in-process dye penetrant test.
P070008/S036
3/18/13
180-Day
Ilesto 7/5 VR-T ICD, Ilesto 7/5
VR-T DX ICD, Ilesto 7/5 DR-T ICD, Ilesto 7/5 HFT CRT-D; Iforia 7/5 VR-T ICD, Iforia
7/5 VR-T DX ICD, Iforia 7/5 DR-T ICD, Iforia 7/5
HF-T CRT-D; and the PSW 1205.U
Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Ilesto 7/5 VR-T ICD, Ilesto 7/5 VR-T DX ICD, Ilesto 7/5 DR-T ICD, Ilesto 7/5 HFT CRT-D; Iforia 7/5 VR-T ICD, Iforia 7/5 VR-T DX ICD, Iforia 7/5 DR-T ICD, Iforia 7/5 HF-T CRT-D; and the PSW 1205.U.
P070008/S039
3/25/13
Real-Time
CardioMessenger II and CardioMessenger    II-S Updates Biotronik, Inc.
Lake Oswego, OR
97035
Approval for updated GSM and landline modems, updated firmware versions, and updates to the device labeling.
P080004/S013
3/13/13
Real-Time
iSert® Gemetric™ Intraocular Lens
(IOL)
Hoya Surgical Optics, Inc.
Chino Hills, CA
91709
Approval for the Model 731 Intraocular Lens (IOL), which adds a controlled positive spherical aberration to the optic. The device, as modified, will be marketed under the trade name iSert® Gemetric™ and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
P080014/S016
3/15/13
Real-Time
Cervista® HPV HR Assay Hologic LP
Marlborough, MA
01752
Approval for a minor labeling change to the Package Insert of the device.
P080025/S042
3/27/13
135-Day
Sacral Nerve Stimulation, Bowel Implantable Neurostimulator (INS) Interstim Family Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for an update to the battery burn-in process and inspection methods.
P080027/S009
3/21/13
Special
OraQuick® HCV Rapid Antibody Test OraSure Technologies, Inc.
Bethlehem, PA
18015
Approval for adding more replicates in QC testing procedures.
P080030/S003
3/5/13
180-Day
iStent Trabecular Micro-Bypass Stent System Glaukos Corporation
Laguna Hills, CA
92653
Approval of the post-approval study protocol.
P080030/S004
3/8/13
180-Day
iStent Trabecular Micro-Bypass Stent System Glaukos Corporation
Laguna Hills, CA
92653
Approval of the post-approval study protocol.
P080030/S005
3/5/13
180-Day
iStent Trabecular Micro-Bypass Stent System Glaukos Corporation
Laguna Hills, CA
92653
Approval of the post-approval study protocol.
P090016/S004
3/8/13
180-Day
BELOTERO Balance Merz Aesthetics, Inc.
Franksville, WI
53126
Approval of the post-approval study protocol.
P090018/S014
3/26/13
Real-Time
Esteem® Envoy Medical Corporation
Saint Paul, MN
55110
Approval for reusable surgical accessories including reusable transducer replicas.
P090026/S005
3/26/13
Real-Time
Access Hybritech p2PSA reagents on the Access Immunoassay System Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the change in polypropylene resin used for the reaction vessel container material that is used as the container for the reaction in the determination of results for Access AFP Reagents, Access Hybritech PSA Reagents, Access Hybritech free PSA Reagents and Access Hybritech p2PSA Reagents; 2) the change in polypropylene resin used for the reagent pack container for Access Hybritech p2PSA Reagents; and 3) the change in polypropylene resin used for the bottle cap for Access AFP Sample Diluent and Access Hybritech PSA Sample Diluent and Access Substrate for Access AFP, Access Hybritech PSA, Access Hybritech free PSA and Access Hybritech p2PSA.
P100003/S001
3/15/13
Special
Secure-C Artificial Cervical Disc Globus Medical, Incorporated
Audubon, PA
19403
Approval for a minor modification of the Narrow Implant Holder (Part #614.805).
P100012/S002
3/29/13
Special
PCM Cervical Disc NuVasive, Incorporated
San Diego, CA 92121
Approval for labeling changes to the Patient Brochure.
P100022/S004
3/1/13
180-Day
Zilver PTX Drug Eluting Stent Cook Medical, Inc.
Bloomington, IN
47402
Approval of the post-approval study protocol.
P100027/S005
3/26/13
180-Day
INFORM HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for hardware modification and software upgrades to the BenchMark ULTRA instrument. The purpose of these design changes was to implement Ultimate Reagent Access (URA) feature on the BenchMark ULTRA instrument.
P100041/S022
3/12/13
Special
Edwards SAPIEN Transcatheter Heart Valve and Accessories Edwards Lifesciences LLC
Irvine, CA
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
P100047/S005
3/4/13
135-Day
HeartWare Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL
33014
Approval to outsource the manufacturing of motor assemblies to a contract manufacturer.
P100049/S004
3/7/13
180-Day
LINX® Reflux Management System Torax Medical, Inc.
Shoreview, MN
55126
Approval for a new esophagus sizing tool that will be used during the implant procedure.
P110010/S035
3/25/13
Special
PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent
System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for modifying the precautions regarding longitudinal stent deformation in the Directions for Use.
P110021/S008
3/12/13
Special
Edwards SAPIEN Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC
Irvine, CA
92614
Approval for additional visual inspection steps for and removal, if found, of fibers and particles on sub-assembled and final assembled replacement heart valves prior to packaging.
P110037/S005
3/21/13
Special
COBAS AmpliPrep/
COBAS® TaqMan® CMV Test
Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for a change to the software Test Definition Files.
P110039/S001
3/15/13
180-Day
ExAblate MRgFUSe® InSightec
Dallas, TX
75244
Approval of the post-approval study protocol.
P110039/S002
3/15/13
180-Day
ExAblate MRgFUSe® InSightec
Dallas, TX
75244
Approval of the post-approval study protocol.
P110042/S002
3/7/13
180-Day
Subcutaneous Implantable Defibrillator System Cameron Health, Inc.
San Clemente, CA 92673
Approval for new sources and formulations of battery cell materials.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N18033/S069
3/5/13
Vistakon (senofilcon A and etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Alternate automatic inspection lens system.
N18033/S070
3/7/13
Vistakon (etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Modification to the release test method.
P790007/S035
3/13/13
Hancock Low Porosity and Modified Orifice Valved Conduit Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine heart valve tissue supplier.
P830055/S130
3/15/13
LCS Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Manufacturing change to the finishing process.
P860003/S072
3/20/13
THERAKOS CELLEX Photopheresis System (CellEx System) Therakos, Inc.
Raritan, NJ
08869
Supplier change for one of the CellEx System components.
P860004/S188
3/22/13
SYNCHROMED II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Repeated use of new manufacturing software.
P860057/S105
3/12/13
Carpentier-Edwards PERIMOUNT Valves Edwards Lifesciences LLC
Irvine, CA
92614
Installation of a new exhaust system for a cleanroom.
P880047/S020
3/12/13
GYNECARE INTERCEED Absorbable Adhesion Barrier Ethicon, Inc.
Somerville, NJ
08876
Change in the configuration of the sterilization pallet used for sterilizing the device.
P910007/S039
3/13/13
ARCHITECT Total PSA Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.
P910077/S132
3/13/13
Latitude Communicator Boston Scientific Corporation
St. Paul, MN
55112
Mechanical modification to flexible printed circuits and modifications to the soldering process parameters for those circuits.
P950029/S074
3/12/13
Pacemaker Models Reply SR and DR; Esprit SR and DR Sorin CRM
Arvada, CO
80004
New automated optical inspection equipment to be used during the micro electronic process.
P950029/S076
3/14/13
REPLY/ESPIRIT FAMILY OF PACEMAKERS Sorin CRM USA, Inc.
Arvada, CO
80004
Modifications to the laser welding program.
P950029/S077
3/20/13
Reply/Esprit SR/DR Pacemakers Sorin Group CRM USA, Inc.
Arvada, CO
80004
Introduction of an alternate supplier for internal blister packaging.
P950029/S078
3/26/13
Reply SR/DR and Espirit SR/DR Pacemakers Sorin Group CRM USA, Inc.
Arvada, CO
80004
Changes to the process limits for gases used to fill finished devices and also updates to the gas concentration limits within the internal atmosphere for the implantable pulse generators.
P960011/S022
3/13/13
BVI 1% OVD (1% sodium hyaluronate viscoelastic surgical aid fluid) Ferring Pharmaceuticals, Incorporated
Parsippany, NJ
07054
Change in the classification of a materials weighing room.
P960040/S287
3/7/13
PUNCTUA® Implantable Cardioverter Defibrillator;
TELIGEN® Implantable Cardioverter Defibrillator; ENERGEN®
Implantable Cardioverter Defibrillator; INCEPTA®
Implantable Cardioverter Defibrillator
Boston Scientific Corporation
Saint Paul, MN 55112
Moving three component receiving acceptance activities from the firm to the component supplier.
P960040/S288
3/7/13
PUNCTA, TELIGEN, ENERGEN, and INCEPTA ICDs Boston Scientific Corporation
Saint Paul, MN 55112
Modification to the capacitor epoxy process.
P970008/S063
3/5/13
CoolWave Targeted Transurethral Thermoablation System (CoolWave System) Urologix, Inc.
Minneapolis, MN
55447
Supplier change for one of the CoolWave System components.
P970031/S039
3/13/13
Freestyle Aortic Root Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine heart valve tissue supplier.
P970051/S106
3/22/13
Nucleus 24 Cochlear Implant System Cochlear Americas Centennial CO
80111
Introduction of alternative new cutting lathes and changes to cutting process monitoring method.
P980007/S030
3/13/13
ARCHITECT Free PSA Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.
P980016/S396
3/13/13
MAXIMO II, PROTECTA, PROTECTA XT, SECURA ICD Medtronic, Inc.
Mounds View, MN
55112
Alternate supplier of a silicone component.
P980016/S397
3/20/13
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD and  Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN
55112
Modification to the seam weld process when using the DLl seam weld equipment.
P980016/S399
3/20/13
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN
55112
IC manufacture Test Changes for the Maximo II ICD D264DRM, D264VRM, D284DRG, D284VRC, Protecta ICD D334DRG, D334DRM, D334VRG, D334VRM, Protecta XT ICD D314DRG, D314DRM, D314VRG, D314VRM, Secura ICD D204DRM, D204VRM, D224DRG, D224VRC, Virtuoso II DR/VR ICD D274DRG and D274VRC.
P980016/S401
3/28/13
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN
55112
New Software version for process data collection software at a Medtronic supplier.
P980016/S402
3/26/13
Maximo, Protecta, Secura, and Virtuoso ICDs Medtronic CRDM
Mounds View, MN
55112
Change to the descum and cleaning processes for the 3μm CMOS Integrated Circuit.
P980022/S132
3/1/13
Paradigm REAL-Time Insulin Pump,
Paradigm REAL-Time Revel Insulin Pump
Medtronic Minimed
Northridge, CA 91325
Update to the Drive Support Disk Dispensing Process at Medtronic Puerto Rico Operations Company for the Paradigm MMT-7XX series.
P980035/S308
3/7/13
Advisa MRI Medtronic CRDM
Mounds View, MN 55112
Multiple manufacturing changes previously accepted for other market released Medtronic devices, which included: 1) CMOS process flow changes at your supplier; 2) Updates to the test software and hardware for integrated circuits; 3) Addition of high temperature monitoring to the high power lean line; 4) Update to a manufacturing assembly controller system; 5) Implementation of a new cleaning process and curing oven; and 6) And implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P980035/S309
3/20/13
Advisa DR IPG, Advisa MRI IPG Medtronic, Inc.
Mounds View, MN
55112
IC manufacture Test Changes for the Advisa DR IPG A4DR01 and Advisa MRI IPG A2DR01.
P980035/S310
3/20/13
Adapta, Versa, Sensia, and Relia Families of Implantable Pulse Generators Medtronic, Inc.
Mounds View, MN
55112
New laser seam welder equipment at the manufacturing facility in Tolochenaz, Switzerland.
P980035/S312
3/28/13
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG Medtronic, Inc.
Mounds View, MN
55112
New Software version for process data collection software at a Medtronic supplier.
P980035/S313
3/26/13
Adapta, Versa, Sensia, Advisa, Advisa MRI, and Relia Pacemakers Medtronic CRDM
Mounds View, MN
55112
Change to the descum and cleaning processes for the 3μm CMOS Integrated Circuit.
P980035/S315
3/28/13
Advisa MRI Medtronic, Inc.
Mounds View, MN
55112
Elimination of the incoming inspection of a battery component at an internal supplier location; reduction in production burn-in time; and an update to the battery burn-in process and inspection methods and associated software.
P980040/S042
3/7/13
TECNIS 1-Piece Lens, TECNIS Multifocal 1-Piece Lens, SENSAR 1-Piece IOL Abbott Medical Optics, Inc.
Santa Ana, CA
92705
New IOL production line, temporary clean/inspect/insert area, a modified deionized water loop support area and a modified compressed air system loop support production area.
P980043/S039
3/13/13
Hancock II Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine heart valve tissue supplier.
P980049/S079
3/12/13
Paradym VR and DR; Paradym RF VR and DR Sorin CRM
Arvada, CO
80004
New automated optical inspection equipment to be used during the micro electronic process.
P980049/S081
3/26/13
Paradym VR/DR and Paradym RF VR/DR Sorin Group CRM USA, Inc.
Arvada, CO
80004
Changes to the process limits for gases used to fill finished devices and also updates to the gas concentration limits within the internal atmosphere for the implantable pulse generators.
P990046/S031
3/29/13
Medtronic Open Pivot™ Heart Valve Medtronic, Inc.
Minneapolis, MN
55432
Addition of a new clean room for sewing cuff sub-assembly component.
P990064/S047
3/13/13
Mosaic Porcine Bioprosthesis Medtronic Heart Valves
Santa Ana, CA 92705
Addition of a new porcine heart valve tissue supplier.
P990074/S025
3/27/13
Natrelle Saline-Filled Breast Implants
Allergan
Goleta, CA
93117
Change the current soaking method from a manual to an automatic process during the manufacturing process.
P000008/S030
3/27/13
LAP-BAND Adjustable Gastric Banding System Allergan Medical
Goleta, CA
93117
Agency to accept a change in the LAP-BAND sterilization validation method.
P000032/S039
3/5/13
Her Option Cryoablation Therapy System Cooper Surgical, Inc.
Trumbull, CT
06611
Addition of a new Gas Supplier and the transfer of Crimping Operations to a different facility.
P000032/S040
3/14/13
Her Option Cryoablation Therapy System Cooper Surgical, Inc.
Trumbull, CT
06611
Change of raw material resin.
P000054/S038
3/27/13
INFUSE® Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Addition of an alternate water supplier.
P000058/S053
3/27/13
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Medtronic Sofamor Danek
Memphis, TN
38132
Addition of an alternate water supplier.
P010012/S322
3/7/13
PUNCTUA® Cardiac Resynchronization Therapy-Defibrillator;
COGNIS® Cardiac Resynchronization Therapy-Defibrillator;
ENERGEN® Cardiac Resynchronization Therapy-Defibrillator;
INCEPTA® Cardiac Resynchronization Therapy-Defibrillator
Boston Scientific Corporation
Saint Paul, MN 55112
Moving three component receiving acceptance activities from the firm to the component supplier.
P010012/S323
3/7/13
PUNCTUA, COGNIS, ENERGEN, and INCEPTA CRT-Ds Boston Scientific Corporation
Saint Paul, MN 55112
Modification to the capacitor epoxy process.
P010015/S189
3/20/13
Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
IC manufacture Test Changes for the Consulta CRT-P C4TR01 and Syncra CRT-P C2TR01.
P010015/S191
3/20/13
Consulta CRT-P, Syncra CRT-P Medtronic, CRDM
Mounds View, MN
55112
Addition of a battery burn-in process to the Universal Burn-In Test System processing and inspection methods and associated software.
P010015/S192
3/28/13
Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
New Software version for process data collection software at a Medtronic supplier.
P010015/S193
3/26/13
Consulta and Syncra CRT-Ps Medtronic CRDM
Mounds View, MN
55112
Change to the descum and cleaning processes for the 3μm CMOS Integrated Circuit.
P010021/S024
3/5/13
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Change to a QC Test Method.
P010029/S016
3/13/13
EUFLEXXA (1% sodium hyaluronate) Ferring Pharmaceuticals, Incorporated
Parsippany, NJ
07054
Change in the classification of a materials weighing room.
P010031/S353
3/5/13
Brava CRT-D, Viva S CRT-D and Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
Change to the hybrid CD Surge manufacturing test software.
P010031/S354
3/7/13
Viva S, and Viva XT CRT-D Systems Medtronic CRDM
Mounds View, MN 55112
Three changes including the implementation of a burn-in oven for the recovery and final voltage measurements steps for the batteries of the subject CRT-D systems, corrections to the subject systems' battery test specification to align with measurement system capabilities, and consolidation of measurement steps within the burn in test process.
P010031/S356
3/5/13
Brava CRT-D, Viva S CRT-D and Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
FACTORY works Release 8.0 and MES Web Services Release 2.1; (2) modification of controlled environment area; (3) new pressure tester at SMO facility; and (4) temporary gowning area and temporary walls and relocation of the milling room.
P010031/S357
3/7/13
Brava CRT-D,
Viva S CRT-D and Viva XT CRT-D
Medtronic CRDM
Mounds View, MN 55112
Multiple manufacturing changes previously accepted for other market released Medtronic devices, which included: 1) CMOS process flow changes at your supplier; 2) Updates to the test software and hardware for integrated circuits; 3) Addition of high temperature monitoring to the high power lean line; 4) Update to a manufacturing assembly controller system; 5) Implementation of a new cleaning process and curing oven; and 6) And implementation of the manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations.
P010031/S358
3/7/13
Brava CRT-D,
Viva S CRT-D, Viva XT CRT-D
Medtronic CRDM
Mounds View, MN
55112
Implementation of additional laser welders to increase manufacturing capacity.
P010031/S359
3/13/13
CONSULTA ICD, MAXIMO II, PROTECTA, PROTECTA XT CRT-D Medtronic, Inc.
Mounds View, MN
55112
Alternate supplier of a silicone component.
P010031/S360
3/20/13
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II CRT-D, Protecta CRT-D and Protecta XT CRT-D Medtronic, Inc.
Mounds View, MN
55112
Modification to the seam weld process when using the DLl seam weld equipment.
P010031/S362
3/20/13
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD,
Maximo II CRT-D, Protecta CRT-D,
Protecta XT CRT-D, Concerto II CRT-D, Consulta, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D
Medtronic, Inc.
Mounds View, MN
55112
IC manufacture Test Changes for the Concerto II CRT-D D274TRK, Consulta DF4 ICD D204TRM, Consulta ICD D224TRK, Maximo II CRT-D D264TRM, D284TRK, Protecta CRT-D D334TRG, D334TRM and Protecta XT CRT-D D314TRG, D314TRM.
P010031/S364
3/28/13
Brava CRT-P, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic, Inc.
Mounds View, MN
55112
New Software version for process data collection software at a Medtronic supplier.
P010031/S365
3/26/13
Viva, Brava, Protecta, Maximo Consulta, and Concerto CRT-Ds Medtronic CRDM
Mounds View, MN
55112
Change to the descum and cleaning processes for the 3μm CMOS Integrated Circuit.
P020056/S019
3/27/13
Natrelle Silicone-Filled Breast Implants
Allergan
Goleta, CA
93117
Change the current soaking method from a manual to an automatic process during the manufacturing process.
P030017/S154
3/8/13
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Update the test equipment system used for the testing of the Implantable Pulse Generator (IPG) Printed Circuit Board Assembly (PCBA).
P030017/S155
3/15/13
Precision and Precision Spectra Spinal Cord Stimulator Systems Boston Scientific Corporation
Valencia, CA
91355
Use alternate biological indicators for monitoring ethylene oxide sterilization.
P040008/S005
3/8/13
VIDAS Total PSA biomérieux, Inc.
Hazelwood, MO 63042
Add an alternate automated purification process to scale-up the anti-PSA antibodies production used in the manufacture of the VIDAS® Total PSA (TPSA) Assay.
P040008/S006
3/13/13
VIDAS Total PSA biomérieux, Inc.
Hazelwood, MO 63042
Addition of an alternate Alkaline Phosphatase (ALP) from the same qualified supplier; it also proposed an improvement to the quality controls performed on this material.
P040024/S068
3/1/13
Restylane Injectable Gel Medics Pharmaceutical Corporation
Scottsdale, AZ
85256
Proposed introduction of a new process vessel used in the bulk and filling process in factory 2.
P040045/S037
3/5/13
Vistakon (senofilcon A and etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Alternate automatic inspection lens system.
P040046/S001
3/27/13
Natrelle Highly Cohesive Silicone-Filled Breast Implants
Allergan
Goleta, CA
93117
Change the current soaking method from a manual to an automatic process during the manufacturing process.
P040047/S025
3/8/13
Coaptite Injectable Implant Merz Aesthetics, Inc.
Franksville, WI
53126
New raw material suppliers.
P050019/S013
3/5/13
Carotid WALLSTENT Monorail Endoprosthesis Boston Scientific Corporation
Natick, MA
01760
Removal of a redundant off-line inspection for extruded components used to manufacture the Carotid WALLSTENT Monorail Endoprosthesis.
P050038/S015
3/21/13
ARISTA AH Absorbable Hemostat Medafor, Inc.
Minneapolis, MN 55430
Proposed introduction of an additional quality control step for the Arista AH Absorbable Hemostat, FlexiTip Applicator Family.
P050042/S022
3/13/13
ARCHITECT Anti-HCV Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.
P050042/S023
3/13/13
ARCHITECT® Anti-HCV Abbott Laboratories
Abbott Park, IL
60064
Add a quality control test for an incoming raw material.
P050051/S020
3/13/13
ARCHITECT AUSAB Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.
P050053/S030
3/27/13
INFUSE® Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Addition of an alternate water supplier.
P060002/S029
3/15/13
FLAIR® Endovascular Stent Graft Bard Peripheral Vascular
Tempe, AZ
85281
Additional laser cutting system as part of the manufacturing process for the FLAIR® Endovascular Stent Graft.
P060007/S026
3/13/13
ARCHITECT HBs/Ag/
Confirmatory
Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.
P060022/S015
3/26/13
Akreos Intraocular Lens Bausch and Lomb Incorporated
Aliso Viejo, CA  92656
Addition of an alternate component supplier.
P060027/S047
3/12/13
Paradym CRT-D; Paradym RF CRT-D Sorin CRM
Arvada, CO
80004
New automated optical inspection equipment to be used during the micro electronic process.
P060027/S049
3/26/13
Paradym CRT-D and Paradym RF CRT-D Sorin Group CRM USA, Inc.
Arvada, CO
80004
Changes to the process limits for gases used to fill finished devices and also updates to the gas concentration limits within the internal atmosphere for the implantable pulse generators.
P060033/S073
3/27/13
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA
95403
Change to automate the information management system
P060035/S019
3/13/13
ARCHITECT CORE-M Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.
P060035/S020
3/13/13
ARCHITECT® CORE Abbott Laboratories
Abbott Park, IL
60064
Add a quality control test for an incoming raw material.
P080023/S020
3/13/13
ARCHITECT CORE Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.
P080023/S021
3/13/13
ARCHITECT® CORE-M Abbott Laboratories
Abbott Park, IL
60064
Add a quality control test for an incoming raw material.
P080027/S010
3/19/13
OraQuick® HCV Rapid Antibody Test OraSure Technologies, Inc
Bethlehem, PA
18015
Change to an in-process test method for HCV antigens and conjugate.
P080030/S007
3/21/13
Glaukos iStent Trabecular Micro-Bypass Stent System Glaukos Corporation
Laguna Hills, CA 92653
Change in a Quality Control Testing procedure
P090003/S021
3/5/13
Express LD Iliac Premounted Stent System Boston Scientific Corporation
Natick, MA
01760
Removal of a redundant off-line inspection for extruded components used to manufacture the Express LD Iliac Premounted Stent System.
P090013/S084
3/26/13
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN
55112
Implementation of automated lead testing equipment.
P090013/S086
3/28/13
Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112
New Software version for process data collection software at a Medtronic supplier.
P090013/S087
3/26/13
Revo MRI Medtronic CRDM
Mounds View, MN
55112
Change to the descum and cleaning processes for the 3μm CMOS Integrated Circuit.
P090016/S006
3/21/13
Belotero Balance Dermal Filler Merz Aesthetics, Inc.
Franksville, WI
53126
Modification to a product release assessment and criteria for finished devices.
P100010/S023
3/21/13
Artic Front Catheters and Artic Front Advance Catheters Medtronic, Inc.
Mounds View, MN
55112
Addition of a new heating process and apparatus to be used in the thermal bonding and forming of the distal tip sections of the catheter shafts.
P100017/S004
3/1/13
Abbott RealTime HCV Abbott Molecular, Inc.
Des Plaines, IL
60018
Change to the configuration of the current label printer, label printing software, and label inspection system at the Des Plaines, Illinois manufacturing site.
P100021/S023
3/25/12
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Additional PET resin supplier.
P100023/S070
3/5/13
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Natick, MA
01760
Removal of a redundant off-line inspection for extruded components used to manufacture the ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System.
P100047/S004
3/1/13
Abbott RealTime HCV Abbott Molecular, Inc.
Des Plaines, IL 60018
Change to the configuration of the current label printer, label printing software, and label inspection system at the Des Plaines, Illinois manufacturing site.
P100047/S017
3/27/13
HeartWare Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Addition of a new coating chamber.
P110010/S048
3/5/13
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Natick, MA
01760
Removal of a redundant off-line inspection for extruded components used to manufacture the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System .
P110013/S008
3/27/13
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA
95403
Change to automate the information management system.
P110015/S048
3/5/13
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Natick, MA
01760
Removal of a redundant off-line inspection for extruded components used to manufacture the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System.
P110019/S042
3/22/13
XIENCE PRIME™, XIENCE PRIME™ LL, and XIENCE Xpedition Everolimus Eluting Coronary Stent Systems (EECSS) Abbott Vascular, Inc.
Temecula, CA
92591
Change the particulate count sampling plan for the XIENCE PRIME, XIENCE PRIME LL, and XIENCE Xpedition EECSS.
P110029/S011
3/13/13
ARCHITECT HBsAg Qualitative/ Confirmatory Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.
P120005/S003
3/26/13
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom Inc.
San Diego, CA 92121
Addition of a laser marking machine used to mark the G4 Transmitter.
P120008/S001
3/13/13
ARCHITECT AFP Abbott Laboratories
Abbott Park, IL
60064
Change an in-process quality control test method to continue production of the anti-HBs negative human plasmas used in the manufacture of the ARCHITECT assays.

Summary of PMA Originals & Supplements Approved
Originals: 1                                                                 
Supplements: 79                                                                     

Summary of PMA Originals Under Review
Total Under Review: 48                                                        
Total Active:17                                                                      
Total On Hold: 31                                                                                          

Summary of PMA Supplements Under Review
Total Under Review: 522                                                      
Total Active: 366                                           
Total On Hold: 156                                                                                        

Summary of All PMA Submissions Received
Originals: 1                                                                 
Supplements: 78                                                         

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 79                                                      
Number of Denials: 0                                     
Average Days Fr Receipt to Decision (Total Time): 139.2      
FDA Time: 102.2 Days      MFR Time: 37 Days

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