|
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 | S264 |
Date Received | 11/03/2016 |
Decision Date | 11/28/2016 |
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 Changes to the integrated circuit wafer manufacturing process flow for the 1.5µm High-density (HD) Bipolar and Complementary Metal Oxide Semiconductor (BiCMOS) at the Singapore AMK6 fabrication facility of Medtronics supplier, STMicroelectronics. |