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Trade Name | Reclaim DBS Therapy for Obsessive Compulsive Disorder System |
Classification Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Generic Name | deep brain stimulator for obsessive compulsive disorder (ocd) |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S246 |
Date Received | 08/21/2020 |
Decision Date | 11/03/2020 |
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 To add the use of tin-lead plating for the terminations of both ends of the tm8 capacitors and to change the solder paste stencil tooling for the 1411 capacitor size for the model 97810 interstim micro ins to increase the amount of solder paste to match the mount used on other capacitor case sizes. |