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Home » FDA releases November 2011 PMAs

FDA releases November 2011 PMAs

February 15, 2011 By MassDevice staff

The Food & Drug Administration released a list of pre-market approvals granted in November 2011:

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P080018
11/3/10
Kodak DirectView CR Mammography System Carestream Health, Inc.
Rochester, NY
14608
Approval for the Kodak DirectView CR Mammography System. This device is indicated for The KODAK DirectView CR Mammography Feature together with KODAK DirectView CR Mammography Cassette comprise a device which, when used in conjunction with a KODAK DirectView CR System and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810031/S038
11/22/10
180-Day
Sodium Hyaluronate Opthalmic Viscoelastic Devices (OVD), Healon®, Healon GV®, Healon 5® Products Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Approval for a labeling change to update the labeling that was approved under PMA supplement P810031/S017 to reflect the Abbott branding guidelines.
P820003/S095
11/10/10
135-Day
Disposable Cover Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P830060/S062
11/10/10
180-Day
 
Lead Tunneler Boston Scientific CRV
St. Paul, MN
55112
Approval for Endotak Reliance 4-Site Leads and Accessories.
P830061/S052
11/10/10
135-Day
CapSure, CapSure Sense, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+, and Vitatron Excellence+ Families of Leads Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P840001/S158
11/1/10
135-Day
Spinal Cord Stimulation Medtronic, Inc. Minneapolis, MN 55432 Approval for changes to electrical test software.
P850089/S066
11/10/10
135-Day
CapSure, CapSure Z Novus, Capsure SP Novus, Capsure Fix, STERx Tip Pacing Lead (ventricular), Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse, and Vitatron Impulse II Families of Leads Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P870072/S045
11/5/10
Real-Time
TLC-II PLUS Portable VAD Driver Thoratec Corporation Pleasanton, CA 94588 Approval for increasing the service interval for the TLC-II PLUS Portable VAD Driver from 4500 hours to 8000 hours.
P890003/S194
11/10/10
135-Day
CapSure Family of Leads, Brilliant S+ VDD Family of Leads, Service Kit-Pacemaker Repair Kit, ECG Cable, Prodigy, Thera-I, Vitatron Legacy, Vitatron Legacy II, and Vitatron Visa Families of IPGs Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P900061/S091
11/10/10
135-Day
Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, Transvene Defibrillation Lead, Epicardial patch lead, and ACE header, Lead end pin cap, Gem, PCD Tachy Control System, Jewel, Micro Jewel, and Micro Jewel II Families of ICDs Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P910073/S077
11/10/10
180-Day
Endotak Reliance 4-Site Lead; 4-Site Terminal Tool; Lead Cap Kit; and 4-Site Lead Pulling Tip Boston Scientific CRV
St. Paul, MN
55112
Approval for Endotak Reliance 4-Site Leads and Accessories.
P910077/S109
11/19/10
Real-Time
Latitude Inductive Communicator Boston Scientific CRM
St. Paul, MN
55112
Approval for modifications to the software for the Latitude Inductive Communicator (Model 6481).
P920015/S061
11/10/10
135-Day
IS-1 Connector Port Pin plug kit, “Y” adaptor/extender kit, Lead adaptor, Sub-Q Tunneling Tool, Sprint, Sprint Quattro, SUBUTANEOUS, Transvene CS/SVC, Transvene DFI, Transvene RV, Transvene SubQ, and Transvene SVC Families of Leads Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P920015/S069
11/10/10
Special
Spring Quattro Medtronic, Inc.
Mounds View, MN 55112
Approval for labeling changes warning physicians about over-retraction of the helix in the subject leads.
P930029/S023
11/10/10
135-Day
RF Marinr, RF Mainr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, RF Contactr Families of Ablation Catheters Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P930039/S039
11/10/10
135-Day
CapSure, CapsureFix Novus, CapsureFix, SureFix, Vitatron Crystalline ActFix, and Vitatron Pirouet S+ Families of Leads Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P940015/S018
11/24/10
135-Day
Synvisc (Hylan G-F 20) and Synvisc-One (Hylan G-F 20) Genzyme Corporation Cambridge, MA 02142 Approval for the introduction of Fedegari autoclave as an additional autoclave in the manufacturing process.
P950024/S021
11/10/10
135-Day
Capsure Epicardial Pacing Family of Leads Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P950037/S083
11/26/10
180-Day
Evia/Entovis Pulse Generators Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the Atrial Capture Control and Ventricular Pacing Suppression features included in version 1002.U/1 programmer software for the Evia/Entovis pulse generators.
P960009/S089
11/1/10
135-Day
Activa® Deep Brain Stimulation Therapy Medtronic, Inc. Minneapolis, MN 55432 Approval for changes to electrical test software.
P960013/S057
11/26/10
180-Day
OptiSense Model 1999 Right Atrial Lead St. Jude Medical Sylmar, CA
91342
Approval for a design change to the header coupling (from a machined component to a molded component) of the OptiSense Model 1999 pacing and sensing lead.
P960016/S034
11/18/10
Real-Time
Safire™ Cardiac Ablation System St. Jude Medical Minnetonka, MN 55345 Approval for a minor design change to widen the minimum angular specification of the pierced hole on the Safire™ shaft.
P960040/S198
11/10/10
180-Day
TELIGEN ICD Guidant Corporation St. Paul, MN
55112
Approval for: 1) the elevated pressure labeling modifications for TELIGEN ICD Models E103, E111, E102 and E110; and 2) the new 4-site header for TELIGEN ICD Models E103 and E111.
P960040/S238
11/19/10
Real-Time
 
Prizm and Vitality Families Boston Scientific CRM
St. Paul, MN
55112
Approval for modifications to the software for the Latitude Inductive Communicator (Model 6481).
P970003/S110
11/5/10
135-Day
VNS Therapy® System Cyberonics, Inc. Houston, TX
77058
Approval to change the generator cleaning process.
P970003/S115
11/18/10
Real-Time
VNS Therapy System Cyberonics, Inc. Houston, TX
77058
Approval for changes to battery longevity design requirements and related labeling of battery longevity tables for the Model 102 and 102R Pulse Generators.
P970003/S116
11/23/10
Real-Time
VNS Therapy System Cyberonics, Inc. Houston, TX
77058
Approval for design modifications and associated labeling changes to the programming software, Model 250 Programming Software.
P970012/S071
11/10/10
135-Day
Kappa 400 Family of IPGs Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P970051/S063
11/24/10
Real-Time
Nucleus 24 Cochlear Implant System Cochlear Americas Centennial, CO 80111 Approval for modifications to the printed circuit board (PCB) of the external CP810 Sound Processor.
P980016/S250
11/10/10
135-Day
Capsure Family of Leads, Entrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo II, Onyx, Secure, Virtuoso, and Virtuoso II Families of ICDs Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P980022/S076
11/17/10
135-Day
Continuous Glucose Monitoring System, Sof-Sensor MMT-7002 Medtronic, Inc. Northridge, CA 91325 Approval for the modifications of the coating process from the spin coating process to the slot coating process, and the adhesion promoter (AP) solution.
P980022/S086
11/1/10
Real-Time
Continuous Glucose Monitoring System Medtronic, Inc. Northridge, CA 91325 Approval for a change to the CareLink® Pro (MMT-7335)-Therapy management software for diabetes, from version 3.0A to 3.0B.
P980035/S177
11/10/10
135-Day
350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 600/700/800/900, Relia, Sensia, Versa, and Sigma Families of IPGs Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P980050/S050
11/10/10
135-Day
CS-SVC Transvene Family of Leads, Jewel AF, and GEM III AT Family of ICDs Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P990001/S072
11/10/10
135-Day
Clarity, DA+ C-Series, DA+ T-Series, Diamond 3, Diamond II, Jade 3, Jade II, Ruby 3, Ruby II, Selection AFm, Topaz 3, Topaz II, Vita, and Vita 2 Families of IPGs Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P990027/S015
11/30/10
180-Day
Technolas Perfect Vision® 217z Zyoptix System for Personalized Vision Correction Technolas Perfect Vision GmbH Munchen, Germany 80992 Approval for the Advanced Nomogram Software Module as an upgrade to the existing software of the Technolas Perfect Vision® 217z Zyoptix System for Personalized Vision Correction. The Advanced Nomogram resides on a separate computer with the Zylink treatment
calculation software, and it leaves all hardware components and the laser beam control software module unchanged. The Technolas Perfect Vision 217z Zyoptix System for Personalized
Vision Correction with Advanced Nomogram Software Module is indicated for wavefront-guided
laser assisted in-situ keratomileusis (LASIK):
1) for the reduction or elimination of myopia with sphere up to -7.00 D and cylinder up to
-3.00 D and MRSE ≤7.50 D at the spectacle plane;
2) in patients with documented evidence of a change in manifest refraction of less than or
equal to ±0.50 diopters (in both cylinder and sphere components) for at least one year
prior to the date of the pre-operative examination; and
3) in patients 21 years of age or older.
P990066/S037
11/5/10
135-Day
GE Healthcare Senographe Digital Mammography System GE Healthcare Waukesha, WI 53188 Approval to replace the current image receptor/detector supplier.
P990081/S008
11/17/10
Special
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc. Tucson, AZ
85755
Approval for changes in quality controls to ensure the safety in the use of the device by: 1) adding a test to ensure appropriate stain intensity of the primary antibody at the bulk manufacturing stages; and
2) adding quality control testing steps at the raw material production and bulk manufacturing stages.
P000009/S040
11/26/10
180-Day
Evia/Entois Pulse Generators Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the Atrial Capture Control and Ventricular Pacing Suppression features included in version 1002.U/1 programmer software for the Evia/Entois pulse generators.
P010012/S212
11/10/10
180-Day
COGNIS CRT-D Guidant Corporation St. Paul, MN
55112
Approval for: 1) the elevated pressure labeling modifications for COGNIS CRT-D Models N120, N118 and N119; and 2) the new 4 site-header for COGNIS CRT-D Model N120.
P010012/S258
11/19/10
Real-Time
Contak and Renewal Families Boston Scientific CRM
St. Paul, MN
55112
Approval for modifications to the software for the Latitude Inductive Communicator (Model 6481).
P010015/S093
11/10/10
135-Day
Attain Family of Leads, InSync, and InSync III Families of CRT-Ps Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P010023/S006
11/5/10
180-Day
Maxum System Ototronix, LLC Houston, TX
77386
Approval for a new EO sterilization site for the packaged Implant Assembly.
P010025/S019
11/16/10
180-Day
Selenia Dimensions 2D Full Field Digital Mammography System Hologic, Inc.
Bedford, MA
01730
Approval for additional Automatic Exposure Control (AEC) technique tables. The device, as modified, will be marketed under the trade name Selenia Dimensions 2D Full Field Digital Mammography System.
P010031/S206
11/10/10
135-Day
Concerto, Concerto II, Consulta, InSync ICD, InSync Marquis, InSync Maximo, InSync II Marquis, Maximo II, InSync II Protect, InSync III Marquis, and InSync Sentry Families of CRT-Ds Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P010032/S034
11/19/10
Special
Implantable Pulse Generator System St. Jude Medical Plano, TX
75024
Approval for the addition of crimp rings in the strain reliefs of the external programming wand cable to improve reliability.
P010032/S035
11/17/10
Special
Implantable Pulse Generator System St. Jude Medical Plano, TX
75024
Approval for labeling changes that clarify the surgical procedures used to implant paddle leads.
P020003/S007
11/10/10
180-Day
Saline Filled Testicular Prosthesis Coloplast Corporation Minneapolis, MN 55411 Approval for the change of the Saline Filled Testicular Prosthesis and the re-branding to “Torosa Testicular Prosthesis”.
P020016/S005
11/8/10
180-Day
Walter Lorenz Total Temporomandibular Joint Replacement System Biomet Microfixation, Inc. Jacksonville, FL 32218 Approval for proposed labeling changes following the conclusion of the postmarket study for the Walter Lorenz Total Temporomandibular Joint Replacement System.
P030010/S006
11/5/10
180-Day
Siemens Mammomat Inspiration DR Full Field Digital Mammography System Siemens Medical Solution USA, Inc. Malvern, PA
19355
Approval for changing the OEM components (detector and image processing) developed by Lorad, the MAMMOMATNovation, to an FFDM system that is designed solely from components designed or specified by Siemens, the MAMMOMATInspiration.
P030036/S018
11/10/10
135-Day
SelectSecure Family of Leads and Anchoring Sleeve Kit Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P040012/S032
11/8/10
135-Day
ACCULINK™ Carotid Stent System Abbott Vascular Temecula, CA 92590 Approval for modifications to the stent laser manufacturing process.
P040021/S012
11/5/10
135-Day
St. Jude Medical Biocor™, Bicor™ Supra, Epic™, and Epic™ Supra Heart Valves St. Jude Medical St. Paul, MN
55117
Approval for removal of a final product quality inspection.
P040025/S011
11/23/10
Real-Time
Olympic Cool-Cap® Natus Medical, Inc. Seattle, WA
98108
Approval for an alternate power supply for the Olympic Cool-Cap System.
P040045/S014
11/18/10
135-Day
VISTAKON® (senofilcon A) Contact Lenses Vistakon – Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 Approval for the implementation of an alternate method for visual inspection of raw materials for VISTAKON® (senofilconA) Contact Lenses, Clear and Visibility Tinted with UV Blocker.
P050012/S027
11/16/10
Real-Time
DexCom Seven and Seven Plus Continuous Glucose Monitoring System DexCom, Inc.
San Diego, CA
92121
Approval for a reduction in standoff as well as addition of shock mounting on the receiver unit of the device.
P050023/S033
11/26/10
180-Day
Evia/Entovis Pulse Generators Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the Atrial Capture Control and Ventricular Pacing Suppression features included in version 1002.U/1 programmer software for the Evia/Entois pulse generators.
P050033/S006
11/5/10
180-Day
Hydrelle™ Dermal Filler Anika Therapeutics, Inc.
Bedford, MA 01730
Approval for a manufacturing site located in Bedford, Massachusetts.
P050048/S005
11/23/10
180-Day
MONOLISA Anti-HBs EIA and MONOLISA Anti-HBs Calibrator Kit Bio-Rad Laboratories Redmond, WA 98052 Approval for a manufacturing site located at Bio-Rad Laboratories in Woodinville, Washington.
P060008/S061
11/16/10
180-Day
 
 
TAXUS™ Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval of the post-approval study protocol.
P060031/S004
11/23/10
180-Day
MONOLISA Anti-HBc EIA Bio-Rad Laboratories Redmond, WA 98052 Approval for a manufacturing site located at Bio-Rad Laboratories in Woodinville, Washington.
P060034/S005
11/23/10
180-Day
MONOLISA Anti-HBc IgM EIA Bio-Rad Laboratories Redmond, WA 98052 Approval for a manufacturing site located at Bio-Rad Laboratories in Woodinville, Washington.
P060037/S009
11/3/10
180-Day
Zimmer NexGen LPS-Flex Mobile & LPS Mobile Bearing Knee Systems Zimmer, Inc.
Warsaw, IN
46581
Approval for the addition of Prolong Highly Crosslinked Polyethylene tibial articular surfaces to the NexGen LPS-Flex Mobile and LPS-Mobile Bearing Knee System.
P060039/S013
11/10/10
135-Day
Attain StarFix Family of Leads Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.
P070001/S005
11/19/10
135-Day
ProDisc C Total Disc Replacement Synthes Spine
West Chester, PA 19380
Approval for a change in the barrel blasting process.
P070008/S017
11/26/10
180-Day
Evia/Entovis Pulse Generators Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the Atrial Capture Control and Ventricular Pacing Suppression features included in version 1002.U/1 programmer software for the Evia/Entois pulse generators.
P080006/S010
11/10/10
135-Day
Attain Family of Leads Medtronic, Inc. Mounds View, MN 55112 Approval for implementation of a new release of traceability software.

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/S049
11/23/10
VISTAKON® (etafilcon A) Contact Lenses Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 Change in a quality control test method for the finished VISTAKON® (etafilcon A) contact lenses.
N18033/S050
11/10/10
VISTAKON® (etafilcon A) Contact Lenses, Clear and Visibility Tinted UV Blocker Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 Implementation of two test methods for the identification of raw materials.
P790007/S027
11/19/10
Hancock® I Modified Orifice Valved Conduit Medtronic, Inc. Santa Ana, CA 92705 Addition of a quality control test for an incoming raw material.
P790007/S028
11/19/10
Hancock® I Modified Orifice Valved Conduit Medtronic, Inc. Santa Ana, CA 92705 Addition of a new tissue adapter.
P820003/S101
11/23/10
Disposable EPG Cover Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P830061/S058
11/23/10
Vitatron Crystaline Lead, Vitratron Excellence+ Lead, Vitatron Excellence PS+ Lead, Capsure SP Lead, Capsure Sense Lead, Capsure, and Capsure SP Novus Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P840001/S167
11/10/10
Itrel 3 Implantable Neurostimulators & Restore Family of Implantable Neurostimulators Medtronic Neuromodulation Minneapolis, MN 55432 Change to a new contract laboratory for inspection procedures.
P840001/S168
11/24/10
Itrel 3 Implantable Neurostimulator, Synergy Family of Implantable Neurostimulators, External Neurostimulators, and Restore Family of Implantable Neurostimulators Medtronic Neuromodulation Minneapolis, MN 55432 Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system.
P840064/S045
11/10/10
DISCOVISC®,
VISCOAT®, DUOVISC®
Alcon Research, Ltd.
Fort Worth, Texas 76134
Expansion of the currently approved cleanroom (including an office area) and the addition of a new material lock for OVD manufacturing processes.
P850089/S071
11/23/10
CapSure Lead, STERx Tip Pacing Lead, CapSure Z Novus Lead, CapSure SP Novus Lead, Vitatron Impulse Lead, Vitatron Impulse II Lead, Vitatron Excellence S+ Lead, Vitatron Excellence SS+ Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P860004/S142
11/3/10
Intrathecal Catheters and Catheter Revision Kit Medtronic Neuromodulation Minneapolis, MN 55432 The addition of a cleaning process to the manufacturing of introducer needles.
P860004/S143
11/24/10
SynchroMed II Infusion Pump Medtronic Neuromodulation Minneapolis, MN 55432 Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system.
P870078/S012
11/19/10
Hancock® Porcine Bioprosthesis, Low Porosity Valved Conduit Medtronic, Inc. Santa Ana, CA 92705 Addition of a quality control test for an incoming raw material.
P870078/S013
11/19/10
Hancock® Porcine Bioprosthesis, Low Porosity Valved Conduit Medtronic, Inc. Santa Ana, CA 92705 The addition of a new tissue adapter.
P880006/S069
11/8/10
Sensolog/Dialog/ Regency Family of Pacemakers St. Jude Medical Sylmar, CA
91392
Change in the adhesive mixing process used in pacemaker and CRT-P manufacturing.
P880086/S194
11/8/10
Affinity/Integrity/ Victory Family of Pacemakers St. Jude Medical Sylmar, CA
91392
Change in the adhesive mixing process used in pacemaker and CRT-P manufacturing.
P890003/S204
11/10/10
Prodigy SR Medtronic, Inc. Mounds View, MN 55112 Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis.
P890003/S205
11/19/10
Medtronic Model 2090 Programmer Medtronic, Inc. Mounds View, MN 55112 Restarting the production of the power supply at a previously approved vendor site.
P890003/S206
11/23/10
ECG Cable, CapSure VDD Leads, Service Kit-Pacemaker Repair Kit, Prodigy IPG, Brilliant S+ VDD Vitatron Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P890047/S033
11/10/10
PROVISC® Alcon Research, Ltd.
Fort Worth, Texas 76134
Expansion of the currently approved cleanroom (including an office area) and the addition of a new material lock for OVD manufacturing processes.
P900061/S096
11/23/10
ACE Header, Lead end pin cap, Epicardial Patch Lead, Upsizing sleeve for Unipolar Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P910001/S038
11/10/10
CVX-300 Excimer Laser System Spectranetics Corporation Colorado Springs, CO
80921
Addition of an alternate DI water supply.
P920015/S068
11/10/10
Sprint Quattro Single Coil IS-1/ DF-1, Active Fix Lead Medtronic, Inc. Mounds View, MN 55112 Transfer of the incoming inspection activities to MPROC Villalba and Juncos facilities.
P920015/S070
11/23/10
Lead adaptor, IS-1 Connector Port Pin Plug Kit, “Y” Adaptor/Extender Kit, Sprint Lead, Transvene DF1 Lead, Transvene RV Lead, Sprint Quattro Lead, Transvene SVC Lead, Transvene CS/SVC Lead, Subcutaneous Lead, Tunneling Tool, Transvene SubQ Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P930014/S046
11/23/10
AcrySof® IQ Toric Intraocular Lenses Alcon Research Ltd.
Fort Worth, TX 76134
Software modification to the Manual Long (low diopter) Wet Aberrometer.
P930029/S027
11/23/10
RF Marinr Catheter, RF Marinr NTC Catheter, 5F RF Marinr Catheter, RF Conductr Catheter, RF Enhancer II Ablation Catheter, RF Contactr Catheter, Conductr Self-Ref, Atakr II Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P930039/S046
11/23/10
CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Vitatron Pirouet+ Lead, Vitatron Crystaline Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P950024/S026
11/23/10
CapSure Epicardial Pacing Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P960009/S099
11/10/10
Activa RC Implantable Neurostimulators & Soletra Implantable Neurostimulators Medtronic Neuromodulation Minneapolis, MN 55432 Change to a new contract laboratory for inspection procedures.
P960009/S100
11/24/10
Soletra Neurostimulator, Kinetra Neurostimulator, Activa Family of Neurostimulators, and External Neurostimulator Medtronic Neuromodulation Minneapolis, MN 55432 Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system.
P960042/S022
11/10/10
SLS II Laser Sheath Spectranetics Corporation Colorado Springs, CO
80921
Addition of an alternate DI water supply.
P970004/S095
11/2/10
InterStim II Neurostimulator Medtronic Neuromodulation Minneapolis, MN 55432 Change to the test specification limits of an existing final functional test.
P970004/S096
11/10/10
InterStim Implantable Neurostimulator Medtronic Neuromodulation Minneapolis, MN 55432 Change to a new contract laboratory for inspection procedures.
P970004/S097
11/24/10
InterStim Neurostimulator and InterStim II Neurostimulator Medtronic Neuromodulation Minneapolis, MN 55432 Implementation of updated hardware and software for the barcode/optical character recognition labeler system as well as a process change pertaining to the upgraded labeler system.
P970012/S075
11/10/10
Kappa 400 DR IPG, Kappa 400 SR IPG Medtronic, Inc. Mounds View, MN 55112 Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis.
P970012/S076
11/23/10
Kappa 400 IPG Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P970013/S037
11/8/10
Microny Family of Pacemakers St. Jude Medical Sylmar, CA
91392
Change in the adhesive mixing process used in pacemaker and CRT-P manufacturing.
P970020/S058
11/1/10
MULTI-LINK Family of Coronary Stent Systems Abbott Vascular Temecula, CA 92590 Discontinuation of the quarterly pyrogen testing of the above named pre- and post-E-beam sterilized products.
P970021/S031
11/23/10
GYNECARE THERMA- CHOICE® III Uterine Balloon Therapy System ETHICON Women’s Health and Urology Somerville, NJ 08876 Change the extrusion process location of two components.
P970031/S030
11/19/10
Freestyle® Aortic Root Bioprosthesis Medtronic, Inc. Santa Ana, CA 92705 Addition of a quality control test for an incoming raw material.
P970031/S031
11/19/10
Freestyle® Aortic Root Bioprosthesis Medtronic, Inc. Santa Ana, CA 92705 Addition of a new tissue supplier.
P980003/S026
11/19/10
CircuCool Pump Boston Scientific Corporation
San Jose, CA
05134
Retrospective outsourcing of components by a supplier.
P980016/S261
11/10/10
Secura DR/VR, Maximo II DR/VR, Virtuoso II DR/VR, Virtuoso ICDs Medtronic, Inc. Mounds View, MN 55112 Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis.
P980016/S262
11/10/10
Secura ICD: D224DRG, D224VRC; Virtuoso II ICD: D274DRG, D274VRC; Maximo II ICD: D284DRG, D284VRC Medtronic, Inc. Mounds View, MN 55112 Implementation of updated hardware and software for the barcode/optical character recognition labeler system used to identify integrated circuit component wafers at your hybrid supplier.
P980016/S263
11/23/10
CapSure Lead, Marquis ICD, Maximo ICD, Intrinsic 30/Intrinsic ICD, EnTrust ICD, Virtuoso ICD, Secura ICD, Virtuoso II ICD, Maximo II ICD Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P980022/S088
11/9/10
Continuous Glucose Monitoring System Sof-Sensor™ Glucose Sensor MMT-7003 Medtronic, Inc. Northridge, CA 91325 Change to extend rinse time for the Sof-Sensor™ Glucose Sensor MMT-7003.
P980035/S189
11/10/10
Kappa 600/700, 650, 800/900, Sigma, Medtronic 350, Enpulse, Adapta/Versa/ Sensia, Relia IPGs Medtronic, Inc. Mounds View, MN 55112 Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis.
P980035/S190
11/10/10
Adapta, Sensia, Versia IPGs: ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, ADSR01, ADSR03, ADSR06, ADVDD01, SED01, SEDR01, SEDRL1, SES01, SESR01 and VEDR01; EnRhythm IPG: P1501DR; Relia IPGs: REDR01, RED01, REVDD01, RESR01, RES01 Medtronic, Inc. Mounds View, MN 55112 Implementation of updated hardware and software for the barcode/optical character recognition labeler system used to identify integrated circuit component wafers at your hybrid supplier.
P980035/S191
11/23/10
Adapta/Sensia/ Versa IPG, AT500 IPG, 350 Series, EnRhythm IPG, EnPulse IPG, Kappa 700 IPG, Kappa 800 IPG, Kappa 900 IPG, Relia IPG, Sigma IPG Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P980043/S028
11/19/10
Hancock® I Porcine Bioprosthesis Medtronic, Inc. Santa Ana, CA 92705 Addition of a quality control test for an incoming raw material.
P980043/S029
11/19/10
Hancock® I Porcine Bioprosthesis Medtronic, Inc. Santa Ana, CA 92705 Addition of a new tissue supplier.
P980050/S055
11/23/10
Transvene CS/SVC Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P990001/S077
11/10/10
C-series IPG, T-series IPG, Dema IPG (includes Clarity DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita 2 DDDR) Medtronic, Inc. Mounds View, MN 55112 Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis.
P990001/S078
11/23/10
Clarity IPG, Vitatron DA+ C-Series IPG, Diamond 3 IPG, Jade 3 IPG, Ruby 3 IPG, Vitatron DA+ T-Series IPG, Topaz 3 IPG, Vita 2 IPG, Vista IPG Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P990020/S042
11/5/10
Medtronic Vascular AneuRx AAAdvantage Stent Graft System Medtronic, Inc. Santa Rosa, CA 95403 The addition of an alternate automatic method for one of the manufacturing processes.
P990023/S010
11/10/10
CELLUGEL® Alcon Research, Ltd.
Fort Worth, Texas 76134
Expansion of the currently approved cleanroom (including an office area) and the addition of a new material lock for OVD manufacturing processes.
P990040/S014
11/10/10
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System Codman & Shurtleff, Inc. Raynham, MA 02767 Change in:
1) supplier of the Ethiodized Oil component of the n-BCA Liquid Embolic System; and 2) the sterilization method for the Ethiodized Oil.
P990064/S035
11/19/10
Mosaic® Porcine Bioprosthesis Medtronic, Inc. Santa Ana, CA 92705 Addition of a quality control test for an incoming raw material.
P990064/S036
11/19/10
Mosaic® Porcine Bioprosthesis Medtronic, Inc. Santa Ana, CA 92705 Addition of a new tissue supplier.
P000014/S022
11/16/10
Vitros Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrators Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 Completion of the relocation of equipment to the new manufacturing site of Pencoed, South Wales.
P000037/S021
11/8/10
On-X® Prosthetic Heart Valve On-X Life Technologies, Inc. Austin, TX
78752
Use of additional manufacturing equipment at the Anderson Lane facility.
P000044/S025
11/16/10
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator; VITROS Immunodiagnostic Products HBsAg Confirmatory Kit Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 Completion of the relocation of equipments to the new manufacturing site of Pencoed, South Wales.
P010015/S101
11/10/10
InSync CRT-P Medtronic, Inc. Mounds View, MN 55112 Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis.
P010015/S102
11/10/10
Attain Leads Medtronic, Inc. Mounds View, MN 55112 Transfer of the incoming inspection activities to MPROC Villalba and Juncos facilities.
P010015/S103
11/23/10
Attain Lead, InSync CRT-P, InSync III CRT-P Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P010031/S217
11/10/10
Concerto II, Consulta, Maximo II, and Concerto Families of CRT-Ds Medtronic, Inc. Mounds View, MN 55112 Changes to the incoming inspection procedures including the type of analysis performed and the location of the laboratory performing the analysis.
P010031/S218
11/10/10
Consulta CRT-D,
Concerto II CRT-D; Maximo II CRT-D
Medtronic, Inc. Mounds View, MN 55112 Implementation of updated hardware and software for the barcode/optical character recognition labeler system used to identify integrated circuit component wafers at your hybrid supplier.
P010031/S219
11/23/10
InSync III Marquis CRT-D, InSync II Marquis CRT-D, InSync Sentry CRT-D, InSync Maximo CRT-D, Concerto CRT-D, Consulta CRT-D, Concerto II CRT-D, Maximo II CRT-D Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P020009/S067
11/19/10
Express 2™ Monorail™ and Over-the-Wire Coronary Stent Systems Boston Scientific, Corporation Maple Grove, MN 55311 Change to product family grouping for the purposes of microbiological sample designation at the Maple Grove manufacturing facilities for pre-sterile product monitoring activities.
P020047/S026
11/1/10
MULTI-LINK VISION® Family of Coronary Stent Systems Abbott Vascular Temecula, CA 92590 Discontinuation of the quarterly pyrogen testing of pre- and post-E-beam sterilized products.
P020052/S007
11/5/10
Response™ CV Cardioversion Electrophysiology Catheter with Lumen St. Jude Medical, Inc.
Minnetonka, MN 55345
Changes to the wire-to-ring and anchor wire brazing process.
P030009/S047
11/1/10
Integrity Coronary Stent System Medtronic Vascular Santa Rosa, CA 95403 Change to the balloon subassembly manufacturing process.
P030009/S048
11/17/10
Integrity Coronary Stent System Medtronic Vascular Santa Rosa, CA 95403 Alternative system for in-process dimensional measurements.
P030017/S110
11/17/10
Precision Spinal Cord Stimulator System (SCS) Boston Scientific Valencia, CA 91355 Addition of an alternate supplier for the Printed Circuit Board (PCB) used in the assembly of SCS Chargers.
P030024/S013
11/16/10
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 Relocation of equipment to the new manufacturing site of Pencoed, South Wales.
P030026/S020
11/16/10
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 Relocation of equipment to the new manufacturing site of Pencoed, South Wales.
P030028/S002
11/23/10
Artisan™ Myopia Phakic IOL Ophtec USA, Inc. Boca Raton, FL 33487 Shortening of Ethylene Oxide degassing phase process and an additional sterilization configuration.
P030035/S074
11/8/10
Frontier/Frontier II Family of CRT-Ps St. Jude Medical Sylmar, CA
91392
Change in the adhesive mixing process used in pacemaker and CRT-P manufacturing.
P030036/S024
11/23/10
SelectSecure Lead, Anchoring Sleeve Kit Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P040012/S035
11/1/10
ACCULINK™ Carotid Stent System Abbott Vascular Temecula, CA 92590 Discontinuation of the quarterly pyrogen testing of pre- and post-E-beam sterilized products.
P040016/S064
11/19/10
VeriFLEX™ Monorail™ and Over-the-Wire Coronary Stent Systems Boston Scientific, Corporation Maple Grove, MN 55311 Change to product family grouping for the purposes of microbiological sample designation at the Maple Grove manufacturing facilities for pre-sterile product monitoring activities.
P040020/S028
11/23/10
AcrySof® IQ ReSTOR® Intraocular Lenses Alcon Research Ltd. Fort Worth, TX 76134 Software modification to the Manual Long (low diopter) Wet Aberrometer.
P040037/S031
11/24/10
Gore VIABAHN® Endoprosthesis W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 Duplicate manufacturing process at the Medical Central Building at the Flagstaff facility.
P040037/S032
11/24/10
Gore VIABAHN® Endoprosthesis W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 Modify a pressure vessel used in the heparin coating process.
P040045/S017
11/10/10
VISTAKON® (senofilcon A) Contact Lenses, Clear and Visibility Tinted with UV Blocker Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 Implementation of test methods for the identification of raw materials, for the VISTAKON® (senofilcon A) Contact Lens materials.
P050020/S026
11/18/10
FreeStyle Navigator Continuous Glucose Monitoring System Abbott Laboratories Alameda, CA
94502
Change to the number of Sensors Delivery Units retained as reserve samples.
P050020/S027
11/23/10
FreeStyle Navigator Continuous Glucose Monitoring System Abbott Laboratories Alameda, CA 94502 Change of the FreeStyle Test Strips from a manual to an automatic process.
P050020/S028
11/23/10
FreeStyle Navigator Continuous Glucose Monitoring System Abbott Laboratories Alameda, CA 94502 New shipping configuration for the Navigator Sensor Delivery Unit (SDU).
P050020/S029
11/23/10
FreeStyle Navigator Continuous Glucose Monitoring System Abbott Laboratories Alameda, CA 94502 Change to verify the presence and location of adhesive channels in the FreeStyle Test Strips.
P050020/S030
11/18/10
FreeStyle Navigator Continuous Glucose Monitoring System Abbott Laboratories Alameda, CA 94502 Modification to the process for coating Freestyle Test Strips with mediator.
P050020/S031
11/23/10
FreeStyle Navigator Continuous Glucose Monitoring System Abbott Laboratories Alameda, CA 94502 Change in the cleaning procedure of the reactors used to make the nPBI mediator chemical used in the FreeStyle Test Strips and the time frame in which this cleaning process takes place.
P060039/S018
11/10/10
Attain Starfix Lead Medtronic, Inc. Mounds View, MN 55112 Transfer of the incoming inspection activities to MPROC Villalba and Juncos facilities.
P060039/S019
11/23/10
Attain StarFix Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P070007/S023
11/5/10
Medtronic Vascular Talent Thoracic Stent Graft System Medtronic, Inc. Santa Rosa, CA 95403 Addition of an alternate automatic method for one of the manufacturing processes.
P070015/S050
11/8/10
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) Abbott Vascular Santa Clara, CA 95054 Modification of a device packaging quality control test.
P070015/S051
11/8/10
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) Abbott Vascular Santa Clara, CA 95054 Increase of a retesting interval.
P070027/S023
11/5/10
Medtronic Vascular Talent Abdominal Stent Graft System Medtronic, Inc. Santa Rosa, CA 95403 Addition of an alternate automatic method for one of the manufacturing processes.
P080006/S016
11/10/10
Attain Ability LV Lead Medtronic, Inc. Mounds View, MN 55112 Transfer of the incoming inspection activities to MPROC Villalba and Juncos facilities.
P080006/S017
11/23/10
Attain Ability Lead Medtronic, Inc. Mounds View, MN 55112 Implementation of an updated version of the Statistical Process Control (SPC) software system across multiple manufacturing locations and vertically integrated suppliers.
P090018/S008
11/23/10
Esteem Envoy Medical Corporation
Saint Paul, MN 55110
Change in the USB cable assembly, and the supplier for the cable, to be used with the Esteem programmer.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 66

Summary of PMA Originals Under Review
Total Under Review: 92
Total Active: 36
Total On Hold: 56
Number Greater Than 180 Days: 4

Summary of PMA Supplements Under Review
Total Under Review: 640
Total Active: 416
Total On Hold: 224
Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received
Originals: 2
Supplements: 80

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 66
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 166.1
FDA Time: 106.6 Days MFR Time: 59.5 Days

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA)

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