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Trade Name | MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS)SYSTEM |
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 |
|
HDE Number | H020007 |
Supplement Number | S003 |
Date Received | 06/01/2004 |
Decision Date | 07/30/2004 |
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 incorporating a polyether urethane material change to the approved model 3307 activa®) dystonia therapy kit (with model 3387 lead and model7482 extension) and model 3309 activa® dystonia therapy kit (with model 3389 lead and model 7482 extension). |