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Trade Name | SOLETRA/LEADS/EXTENSIONS/ACTIVA THERAPY DYSTONIA KIT |
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 | S055 |
Date Received | 12/12/2011 |
Decision Date | 02/03/2012 |
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 the remove the model 3655 tunneling tool from the model 7482a and model 37085 extension kits. With the exception of the removal of the tunneling tool and tunneling tool accessories the extension and extension accessories are identical to the approved extension and extension accessories. |