|
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 | S428 |
Date Received | 05/11/2022 |
Decision Date | 05/24/2022 |
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 Change the testing of the M960543A Stim Integrated Circuit and the M960545A Multi-Function Integrated Circuit wafer products from the LTX to the SPEA Compact Automated Test Equipment at the Medtronic Tempe Campus. |