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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 | S165 |
Date Received | 09/01/2017 |
Decision Date | 03/11/2018 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at medronic puerto rico operations company, villalba, rd. 149, km 56. 3 , cal box 6001, villaba, puerto rico for manufacture of the 1x4 pocket adaptors (models 74001 and 64001) and 2x4 pocket adaptors (models 74002 and 64002). |