|
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 | S382 |
Date Received | 08/21/2020 |
Decision Date | 11/03/2020 |
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 the use of tin-lead plating for the terminations of both ends of the TM8 capacitors and to change the solder paste stencil tooling for the 1411 capacitor size for the Model 97810 InterStim Micro INS to increase the amount of solder paste to match the mount used on other capacitor case sizes. |