|
Device | MEDTRONIC ACTIVA PARKINSON¿S CONTROL THERAPY |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S080 |
Date Received | 04/01/2010 |
Decision Date | 04/30/2010 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ADDING A WARNING TO BOTH THE PHYSICIAN AND PATIENT MANUALS. |
Post-Approval Study | Show Report Schedule and Study Progress |