Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | ACTIVA IMPLAMTABLE NEUROSTIMULATORS: ACTIVA RC MODEL 37612, ACTIVA PC MODEL 37601, ACTIVA SC MODEL 37602 AND ACTIVA SC M |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S149 |
Date Received | 06/22/2012 |
Decision Date | 08/24/2012 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ELIMINATING THE EXTERNAL PARYLENE COATING FROM THEFOLLOWING IMPLANTABLE NEUROSTIMULATORS: ACTIVA RC MODEL 37612, ACTIVA PC MODEL 37601, ACTIVA SC MODEL 37602 AND ACTIVA SC MODEL 37603. |
Post-Approval Study | Show Report Schedule and Study Progress |
|
|