|
Device | ACTIVA PC 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 | S071 |
Date Received | 08/28/2009 |
Decision Date | 10/27/2009 |
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 REDESIGN OF THE 6-PIN FILTERED FEEDTHROUGH. |
Post-Approval Study | Show Report Schedule and Study Progress |