PMA P960009S546

Device: MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S546
Product code: MHY
Decision date: 2026-09-24
Classification: Neurology
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: approval for implementation of a manufacturing process change that will update the manufacturing execution system flow for the affected feedthrough product family

Current openFDA PMA Record#

Device: MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S546
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2026-09-24
Decision code: OK30
Date received: 2026-08-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for implementation of a manufacturing process change that will update the manufacturing execution system flow for the affected feedthrough product family