PMA P960009S382

Device: Activa Deep Brain Stimulation Therapy System
Applicant: Medtronic, Inc.
Product code: MHY
Decision date: 2020-11-03
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
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.

Current openFDA PMA Record#

Device: Activa Deep Brain Stimulation Therapy System
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S382
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2020-11-03
Decision code: APPR
Date received: 2020-08-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.