|
Device | Activa Deep Brain Stimulation Therapy System and 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 | S398 |
Date Received | 03/05/2021 |
Decision Date | 03/31/2021 |
Product Code |
MHY |
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 Automating the manual process of updating preloaded Data Flash Image (DFI) that manages battery performance for the FOB component. |