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Trade Name | Reclaim DBS Therapy for Obsessive Compulsive Disorder (OCD) 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 | S242 |
Date Received | 08/04/2020 |
Decision Date | 08/12/2020 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of changes being effected (cbe) for the enhancement and harmonization of the physician and patient labeling to include precaution statements regarding risks of loss of coordination during activities requiring coordination (e. G. Swimming) and bathing in the labeling across the device type, as requested in the fda labeling change request letter dated june 12, 2020 and updated label change request via email on june 25, 2020. |