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Trade Name | Activa® Dystonia Therapy System, Percept™ PC BrainSense™ |
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 | S312 |
Date Received | 01/26/2022 |
Decision Date | 04/06/2022 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement For an update to the primary information for prescribers (ifp) clinician labeling, and update to the primary patient therapy guide (ptg) to mitigate the potential for implantable neurostimulator (ins) malfunction during a cardioversion procedure. |