|
Device | 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 | S433 |
Date Received | 07/05/2022 |
Decision Date | 08/03/2022 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to 1) Change in Exclusion Criterion #4 to state Previous diagnosis of psychogenic/non-epileptic seizures within the 12 months prior to the Enrollment Visit; and 2) Change in Implant Eligibility Criterion #4 to state, Change to: No suicide attempt or other self-harm behaviors within past year (assessed by C-SSRS at 3-month CMM Visit). |