Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device. |
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Trade Name | Reclaim® DBS Therapy for Obsessive Compulsive Disorder (OCD) System |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S292 |
Date Received | 10/18/2022 |
Decision Date | 11/16/2022 |
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 To implement a new external function used in finished device manufacturing that will automate pass or fail decisions on global monitors. |
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