|
Device | MEDTRONIC ACTIVA TREMOR CONTROL 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 | S002 |
Date Received | 03/05/1998 |
Decision Date | 09/01/1998 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of a protocol to assess the neurotoxicity and carcinogenicity of the Medtronic Model 3387 DBS Lead. The work performed under this protocol is intended to fulfill one of the four conditions of approval of the PMA. |