|
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 | S448 |
Date Received | 03/07/2023 |
Decision Date | 03/16/2023 |
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 Transfer the cleaning of the Contact Multi-Beam Welded (referred to as MBC) component from Medtronic Rice Creek to the Villalba facility toensure product availability and increase capacity and flexibility at the Villalba site. |