FDA 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. |