|
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 | S309 |
Date Received | 01/05/2018 |
Decision Date | 06/02/2018 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for adding an alternate supplier to manufacture the coil components used in the implanted leads of the Deep Brain Stimulator (DBS), Spinal Cord Stimulation (SCS), and Sacral Nerve Stimulation (SNS) devices. |