Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™ |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S419 |
Date Received | 01/26/2022 |
Decision Date | 04/06/2022 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval 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. |
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