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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 | S227 |
Date Received | 11/15/2019 |
Decision Date | 12/11/2019 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Update medtronics manufacturing software, manufacturing execution system to factory works (release 9. 7), which is comprised of (1) fw business rule client 9. 7, (2) fw configuration client 9. 2. 2, and (3) integrated manufacturing process management (impm) web services (ws) 3. 6. |