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Trade Name | ACTIVA/ KINETRA/ SOLETRA DEEP BRAIN STIMULATION SYSTEMS |
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 | S080 |
Date Received | 03/28/2014 |
Decision Date | 04/24/2014 |
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 the software used at several medtronic¿s manufacturing facilities. |