PMA P960009S398

Device: Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S398
Product code: MHY
Decision date: 2021-03-31
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement: Automating the manual process of updating preloaded Data Flash Image (DFI) that manages battery performance for the FOB component.

Current openFDA PMA Record#

Device: Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense
Applicant: Medtronic, Inc.
PMA number: P960009
Supplement: S398
Product code: MHY
Generic name: Stimulator, electrical, implanted, for parkinsonian tremor
Decision date: 2021-03-31
Decision code: OK30
Date received: 2021-03-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Automating the manual process of updating preloaded Data Flash Image (DFI) that manages battery performance for the FOB component.