FDA.reportPublic FDA data

PMA P960009S437

Device
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S437
Product code
MBX
Decision date
2022-09-07
Generic name
Stimulator, thalamic, epilepsy, implanted
Approval order statement
Repositioning of equipment (and cleanroom) within the existing manufacturing facility of a critical supplier to Medtronic that manufactured fabricated metal components.

Current openFDA PMA Record#

Device
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S437
Product code
MBX
Generic name
Stimulator, thalamic, epilepsy, implanted
Decision date
2022-09-07
Decision code
OK30
Date received
2022-08-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Repositioning of equipment (and cleanroom) within the existing manufacturing facility of a critical supplier to Medtronic that manufactured fabricated metal components.