|
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 | S336 |
Date Received | 12/18/2018 |
Decision Date | 03/01/2019 |
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 add a Polyethylene terephthalate (PET) slip tube over proximal end of each cable conductor to prevent mechanical locking of the build epoxy to the Ethylene tetrafluoroethylene (ETFE) coated wire cables for DBS Extension models 37085 and 37086. |