Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ACTIVA DEEP BRAIN STIMULATION THERAPY 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 | S243 |
Date Received | 12/14/2015 |
Decision Date | 02/29/2016 |
Product Codes |
MHY NHL |
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 addition of new/updated safety information, specifically a warning for status dystonicus (for dystonia labeling) and potential adverse events, and the consolidation of therapy-wide adverse events supplemented by indication-specific labeling addenda. |
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