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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 |
|
HDE Number | H020007 |
Supplement Number | S096 |
Date Received | 09/09/2013 |
Decision Date | 10/03/2013 |
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 Updates to the current final packlabel printing equipment controller, which is used during the sterile final package operation atmedtronic puerto rico operations company (mproc) in villalba, puerto rico. |