PMA P960009S532

Device
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S532
Product code
MHY
Decision date
2026-04-03
Classification
Neurology
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor

Current openFDA PMA Record#

Device
Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S532
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2026-04-03
Decision code
OK30
Date received
2026-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier