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Device | SOLETRA AND ITREL II NEUROSTIMULATORS FOR DEEP BRAIN STIMULATION (DBS) SOFTWARE |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S025 |
Date Received | 05/10/2002 |
Decision Date | 10/31/2002 |
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 8870 N'VISION APPLICATION CARD. THE MODEL 8870 N'VISION APPLICATION CARD IS AN ACCESSORY TO THE SOLETRA AND ITREL II NEUROSTIMULATORS FOR DBS. |