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Trade Name | ACTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS |
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 | S035 |
Date Received | 04/04/2012 |
Decision Date | 04/23/2012 |
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 labeling changes regarding recharger use in the iniormation for prescribers manual -- medtronic dbs therapy. |