FDA.reportPublic FDA data

PMA P960009S449

Device
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S449
Product code
MBX
Decision date
2023-03-10
Classification
Neurology
Generic name
Stimulator, thalamic, epilepsy, implanted
Approval order statement
Update process monitoring controls (sample sizes and control limits) as part of the implementation of Statistical Process Control (SPC) program at Medtronic Vascular.

Current openFDA PMA Record#

Device
Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S449
Product code
MBX
Generic name
Stimulator, thalamic, epilepsy, implanted
Decision date
2023-03-10
Decision code
OK30
Date received
2023-03-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update process monitoring controls (sample sizes and control limits) as part of the implementation of Statistical Process Control (SPC) program at Medtronic Vascular.