|
Device | ACTIVA TREMOR CONTROL THEREAPY SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S019 |
Date Received | 07/03/2001 |
Decision Date | 12/31/2001 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL 7438 THERAPY CONTROLLER WHICH IS INTENDED TO BE USED AS AN ALTERNATIVE TO THE EXISTING MODEL 7452 CONTROL MAGNET AS A COMPONENT OF THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM. |