|
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 | S308 |
Date Received | 12/18/2017 |
Decision Date | 01/11/2018 |
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 Software updates to a final functional test performed on Medtronic Restorative Therapies Group (RTG) therapies' recharging systems. This change is to allow the final functional test software to correctly measure the standby current for the Current Drain Standby Mode Test. |