FDA.reportPublic FDA data

PMA P960009S368

Device
Activa Deep Brain Stimulation Therapy System
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S368
Product code
MHY
Decision date
2020-02-05
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement
Change in the destructive testing pull test sampling, sampling frequency, and tightening of the control limits established for the pull test monitoring.

Current openFDA PMA Record#

Device
Activa Deep Brain Stimulation Therapy System
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S368
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2020-02-05
Decision code
OK30
Date received
2020-01-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change in the destructive testing pull test sampling, sampling frequency, and tightening of the control limits established for the pull test monitoring.