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Trade Name | RECLAIM DEEP BRAIN STIMULATION FOR OBSESSIVE COMPULSIVE DISORDER (OCD)THERAPY |
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 | S052 |
Date Received | 10/05/2012 |
Decision Date | 12/14/2012 |
Product Code | |
Notice Date | 12/14/2012 |
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 minor changes to model 8840 n'vision programmer software for end of service and low/empty reservoir alarms. |