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Trade Name | ACTIVA PC AND SC IMPLANTABLE DEEP BRAIN STIMULATORS |
Classification Name | stimulator, brain, implanted, for behavior modification |
Generic Name | stimulator, brain, implanted, for behavior modification |
Applicant |
MEDTRONIC INC.,NEUROLOGICAL DIVISION |
7000 central avenue northeast |
minneapolis, MN 55432 |
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HDE Number | H050003 |
Supplement Number | S065 |
Date Received | 07/29/2013 |
Decision Date | 08/27/2013 |
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 Change to include an additionalincoming material acceptance test method for underfill epoxy. |