|
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 | S304 |
Date Received | 11/16/2017 |
Decision Date | 05/26/2018 |
Product Codes |
MBX MHY NHL |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for Medtronics new model A610 Activa Clinician Programmer application and Model 8880T2 Communicator intended for programming DBS systems and for a field-implementable update to the Model 37612 Activa RC implantable neurostimulator to extend the service life from 9 years to 15 years. |