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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 | S054 |
Date Received | 07/29/2011 |
Decision Date | 08/26/2011 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling changes to the manual for the model 8840 n'vision clinician programmer. These changes include the addition of precautions related to modificationof the device, the effect of electromagnetic interference (emi) on telemetry communication, and the effects of battery corrosion. The changes also include updates to existing precautionary language to maintain consistency with other medtronic labeling for external programming devices. |