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Trade Name | RECLAIM DBS THERAPY FOR OBSESSIVE COMPULSIVE DISORDER (OCD) SYSTEM |
Classification Name | stimulator, brain, implanted, for behavior modification |
Generic Name | stimulator, brain, implanted, for behavior modification |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S120 |
Date Received | 12/14/2015 |
Decision Date | 02/29/2016 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
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. |