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Trade Name | Reclaim DBS Therapy for Obsessive Compulsive |
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 | S211 |
Date Received | 03/21/2019 |
Decision Date | 04/15/2019 |
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 for changes to the medtronic communicator model 8880t2 technical manual and clinician programmer application labeling. |