|
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 | S399 |
Date Received | 03/08/2021 |
Decision Date | 04/06/2021 |
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 Modification to the Implantable Neurostimulator (INS) devices weld monitoring method from a manual peel test to an automated pull test. |