|
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 | S281 |
Date Received | 05/03/2017 |
Decision Date | 05/25/2017 |
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 Qualify an alternate BalSeal manufacturing site facility for the spring coil components (Colorado Springs) and to update the tooling used for the insertion testing of the contact assembly from a uni-directional test pin to a bi-directional test pin. |