A blog about what is new (and old) in the world of active implantable medical devices 

Facebook Twitter Gplus Flickr LinkedIn YouTube RSS
magnify
Home AIMD Business FDA AIMD PMA/Supplement Approvals for January
formats

FDA AIMD PMA/Supplement Approvals for January

FDA logoFDA released its PMA/Supplement approvals for January.   The edited version below has been edited to include only AIMDs.  It is not the full list, and should be used only for general information purposes.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL

DEVICE   TRADE NAME

COMPANY NAME CITY,   STATE, & ZIP

DEVICE   DESCRIPTION / INDICATIONS

P860004/S151
1/13/12
135-Day
SynchroMed II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for a manufacturing change related to the   desiccant inspection step for the SynchroMed II Infusion Pump, Model 8637.
P910073/S091
1/5/12
180-Day
ENDOTAK RELIANCE IS-1 Passive Fixation Leads BostonScientific CRV
St. Paul, MN
55112
Approval for drug material and supplier changes as well as   distal tip design changes.
P920015/S055
1/9/12
180-Day
Medtronic® Sprint Quattro Secure® Defibrillation Lead Medtronic, Inc.
Mounds View, MN
55112
Approval for the DF4 Connector System, which is comprised   of the ICD, CRT-D and defibrillation lead devices for the devices.
P980016/S216
1/9/12
180-Day
Medtronic® Secura® DR D204DRM and Maximo® II D264DRM   Implantable Cardioverter Defibrillators, Model 9995 v7.3 application software Medtronic, Inc.
Mounds View, MN
55112
Approval for the DF4 Connector System, which is comprised   of the ICD, CRT-D and defibrillation lead devices for the devices.
P000040/S020
1/24/12
180-Day
Genesys HTA™ System BostonScientific   Corporation
Marlborough, MA
01752
Approval for software changes to the Genesys HTA System   control Unit.
P010031/S176
1/9/12
180-Day
Medtronic® Consulta® CRT-D D204TRM and Maximo® II CRT-D   D264TRM Implantable Cardioverter Defibrillators with Cardiac   Resynchronization, Model 9995 v7.3 application software Medtronic, Inc.
Mounds View, MN
55112
Approval for the DF4 Connector System, which is comprised   of the ICD, CRT-D and defibrillation lead devices for the devices.

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

P840001/S201
1/12/12
RestoreSensor Implantable Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Three software changes, automation of the Bond Pad Array   manufacturing process, and minor changes to the ethylene oxide residual   testing procedures.
P840001/S202
1/13/12
Spinal Cord Stimulation (SCS) Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of two new desktop welding stations with updated   power supplies, and two process changes to include the consolidation of   production laser weld program code and reducing frequency parameters for the   welding process.
P840001/S203
1/20/12
Itrel 3 Implantable Neurostimulator, Synergy Family of   Implantable Neurostimulators and Restore Family of Implantable   Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Thermal processing of Eccobond epoxy resin E3450(A) prior   to consumption in routine manufacturing.
P890003/S243
1/18/12
Prodigy IPGs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing   component used during routine manufacturing.
P960009/S135
1/13/12
Deep Brain Stimulation (DBS)
Leads
Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of two new desktop welding stations with updated   power supplies, and two process changes to include the consolidation of   production laser weld program code and reducing frequency parameters for the   welding process.
P960009/S136
1/20/12
Soletra Neurostimulator, Kinetra Neurostimulator and   Activa Family of Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Thermal processing of Eccobond epoxy resin E3450(A) prior   to consumption in routine manufacturing.
P960040/S247
1/13/12
Teligen, Incepta, Energen, Punctua ICDs BostonScientific   Corporation
St. Paul, MN
55112
Use of a new cathode material in the high voltage capacitor   and a new supplier.
P960040/S248
1/19/12
Teligen, Incepta, Energen, Punctua CRT-Ds BostonScientific CRM
St. Paul, MN
55112
Addition of a new supplier for a resistor component.
P960040/S249
1/25/12
Teligen, Incepta, Energen, Punctua ICDs BostonScientific   Corporation
St. Paul, MN
55112
Manufacture of the battery component to be manufactured   internally at its Boston     Scientific
St. Paul manufacturing facility.
P960040/S250
1/26/12
TELIGEN, INCEPTA, ENERGEN, PUNCTUA and CONFIENT   Implantable Cardioverter Defibrillators BostonScientific   Corporation
St. Paul, MN
55112
Addition of a new supplier for the antenna sock component,   and for changes to the receiving acceptance activities.
P970004/S127
1/13/12
InterStim Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of two new desktop welding stations with updated   power supplies, and two process changes to include the consolidation of   production laser weld program code and reducing frequency parameters for the   welding process.
P970004/S128
1/20/12
InterStim Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Thermal processing of Eccobond epoxy resin E3450(A) prior   to consumption in routine manufacturing.
P970012/S129
1/31/12
Interstim Sacral Nerve Stimulation Therapy System, Test   Stimulation Lead and Stimulation Lead Kit Medtronic Neuromodulation
Minneapolis, MN
55432
Alternate supplier for a process for coating conductor   wire.
P970012/S090
1/18/12
Kappa 400 DR/SR IPGs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing   component used during routine manufacturing.
P980016/S333
1/18/12
Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II,   Virtuoso II, Secura, Protecta XT, Protecta, and ProtectaXT/Protecta DF4 ICDs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing   component used during routine manufacturing.
P980035/S255
1/18/12
Kappa 700/800/900, Sigma, Medtronic 350, EnPulse,   EnRhythm, AT500, Adapta/Versa/
Sensia, Relia and Advisa DR IPGs
Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing   component used during routine manufacturing.
P980049/S068
1/11/12
Paradym VR and Paradym DR ICDs Sorin CRM USA, Inc.
Plymouth, MN
55441
In-sourcing of an electronic assembly.
P990001/S099
1/18/12
Dema, C-Series and T-Series IPGs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing   component used during routine manufacturing.
P010012/S275
1/13/12
Cognis,   Incepta, Energen, Punctua CRT-Ds BostonScientific   Corporation
St. Paul, MN
55112
Use of a new cathode material in the high voltage   capacitor and a new supplier.
P010012/S276
1/19/12
Cognis,   Incepta, Energen, Punctua CRT-Ds BostonScientific CRM
St. Paul, MN
55112
Addition of a new supplier for a resistor component.
P010012/S277
1/25/12
Cognis,   Incepta, Energen, Punctua CRT-Ds BostonScientific   Corporation
St. Paul, MN
55112
Manufacture of the battery component to be manufactured   internally at its Boston     Scientific
St. Paul manufacturing facility.
P010012/S278
1/26/12
COGNIS, INCEPTA, ENGERGEN, PUNCTUA, LIVIAN Cardiac   Resynchronization Therapy-Defibrillators BostonScientific   Corporation
St. Paul, MN
55112
Addition of a new supplier for the antenna sock component,   and for changes to the receiving acceptance activities.
P010015/S151
1/18/12
InSync, InSync III, Consulta and Syncra CRT-Ps Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing   component used during routine manufacturing.
P010031/S286
1/18/12
InSync Marquis, InSync II Marquis, InSync III Marquis,   InSync Sentry, and Insync Maximo ICDs and Concerto, Concerto II, Maximo II,   Consulta, Protecta XT, Protecta and Protecta DF4
CRT-Ds
Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing   component used during routine manufacturing.
P010032/S044
1/6/12
The EonMini IPG St. Jude Medical
Plano, TX
75024
Add a backside lamination to components installed on the   printed circuit board (PCB).
P010032/S045
1/19/12
Genesis, Eon, EonC Eon Mini Neurostimulation Systems St. Jude Medical
Piano, TX
75024
Manufacturing process change to add an in-process   inspection step for the devices.
P030017/S125
1/4/12
Precision Spinal Cord Stimulator (SCS) System Boston   Scientific Neuromodulation
Valencia, CA
91355
A new fabrication site for the supplier of the Analog   Integrated Circuit (IC) in the Printed Circuit Board Assembly (PCBA) of the   Implantable Pulse Generator (IPG) for the Precision Spinal Cord Stimulator   (SCS) System.
P060027/S035
1/11/12
Paradym CRT-D Sorin CRM USA, Inc.
Plymouth, MN
55441
In-sourcing of an electronic assembly.
P080025/S024
1/13/12
InterStim Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of two new desktop welding stations with updated   power supplies, and two process changes to include the consolidation of   production laser weld program code and reducing frequency parameters for the   welding process.
P080025/S025
1/20/12
InterStim II Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Thermal processing of Eccobond epoxy resin E3450(A) prior   to consumption in routine manufacturing.
P080025/S026
1/30/12
Interstim Sacral Nerve Stimulation Therapy System, Test   Stimulation Lead and Test Stimulation Lead Kit Medtronic Neuromodulation
Minneapolis, MN
55432
Alternate supplier for a process for coating conductor   wire.
P090013/S049
1/18/12
Revo MRI IPGs Medtronic, Inc.
Mounds View, MN
55112
Implementation of thermal processing for a manufacturing   component used during routine manufacturing.

 

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off  comments