PMA P960009S395

Device: Activa® Deep Brain Stimulation Therapy System
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S395
Product code: MHY
Decision date: 2021-02-10
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Manufacturing location change of polymer resin for an external supplier, AGC Chemicals, and change in a processing aid used in the production of ETFE due to the environmental regulations.

Current openFDA PMA Record#

Device: Activa® Deep Brain Stimulation Therapy System
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S395
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2021-02-10
Decision code: OK30
Date received: 2021-01-11
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Manufacturing location change of polymer resin for an external supplier, AGC Chemicals, and change in a processing aid used in the production of ETFE due to the environmental regulations.