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 | 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 | S043 |
Date Received | 06/22/2012 |
Decision Date | 08/24/2012 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for eliminating the external parylene coating from the following implantable neurostimulators: activa rc model 37612, activa pc model 37601,activa sc model 37602, and activa sc model 37603. |
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