|
Device | ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATOR |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S138 |
Date Received | 03/22/2012 |
Decision Date | 04/20/2012 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement REDUCE THE SAMPLE SIZE FOR PARALLEL GAP WELD LINE TESTING ON PLATED COMPONENTS. |
Post-Approval Study | Show Report Schedule and Study Progress |