|
Device | Activa Deep Brain Stimulation Therapy System |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S323 |
Date Received | 08/28/2018 |
Decision Date | 09/21/2018 |
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 Three (3) manufacturing changes that will further align the manufacturing of Medtronic’s newly approved Model 37441 Intercept Patient Programmer with existing manufacturing of other market approved Medtronic products: 1) FACTORYworks MES Upgrade to Version 9.3; 2) Patient Programmer Real-Time Clock Capacitor Change; and 3) Patient Programmer Heating. |