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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 | S058 |
Date Received | 02/11/2013 |
Decision Date | 12/06/2016 |
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 Changing the tubing material from the prior mdx silicone resin to the nusil med 4719 silicone resin. |