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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 | S101 |
Date Received | 02/27/2015 |
Decision Date | 05/12/2015 |
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 material changes to two non-implantable screening cables (the alligator clip screening cable accessory kit and the twist lock screening cable accessory kit) to comply with the european union restriction of hazardous substances ii directive 2011/65/eu. |