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Trade Name | AVTIVA FAMILY OF IMPLANTABLE NEUROSTIMULATORS |
Classification Name | implanted subcortical electrical stimulator (motor disorders) |
Generic Name | implanted subcortical electrical stimulator (motor disorders) |
Applicant |
MEDTRONIC NEUROMODULATION |
7000 central avenue ne |
rcw 225 |
minneapolis, MN 55432 |
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HDE Number | H020007 |
Supplement Number | S069 |
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. |