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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 | S003 |
Date Received | 10/08/1998 |
Decision Date | 09/30/1999 |
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 |
Approval Order Statement Approval for the Model 3389 DBS(TM) Lead (as an alternative tot he existing Model 3387 DBS(TM) Lead) for use in conjunction with the existing Medtronic Activa Tremor Control System. |