|
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 | S337 |
Date Received | 12/26/2018 |
Decision Date | 03/08/2019 |
Product Code |
MHY |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to a change in material purity of niobium wire stock; second-tier raw material supplier change for niobium wire stock; lubricant change for wire drawing process; and process change to anneal wire prior to wire drawing process. |