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Trade Name | EXTERNAL NEUROSTIMULATOR,ACTIVA PC NEUROSTIMULATOR,ACTIVA SC NEUROSTIMULATOR,ACTIVA SC NEUROSTIMULATOR |
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 | S103 |
Date Received | 11/13/2013 |
Decision Date | 12/13/2013 |
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 Addition of alternate suppliers to manufacture the silicone seal compression assemblies. |