|
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 | S426 |
Date Received | 05/03/2022 |
Decision Date | 05/12/2022 |
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 Changes to the final acceptance procedures for hybrid modules and assemblies and the hybrid final pack and bag RFID process specifications procedures to correct identified gaps in standard work as determined during a CAPA investigation. |