|
Device | ACTIVA THERAPY FOR DEEP BRAIN STIMULATION |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S042 |
Date Received | 09/17/2007 |
Decision Date | 10/17/2007 |
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 |
Approval Order Statement APPROVAL FOR TE ADDITION OF A PRECAUTION TO PATIENT MANUALS OF THE MODEL 7436 AND MODEL 7438 THERAPY CONTROLLERS. |