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 | EXTERNAL NEUROSTIMULATORS,ACTIVA PC NEUROSTIMULATOR,ACTIVA SC 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 | S067 |
Date Received | 09/09/2013 |
Decision Date | 10/03/2013 |
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 Updates to the current final packlabel printing equipment controller, which is used during the sterile final package operation atmedtronic puerto rico operations company (mproc) in villalba, puerto rico. |
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