PMA P960009S271

Device
Activa Deep Brain Stimulation Therapy System
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S271
Product code
MHY
Decision date
2017-03-23
Classification
Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement
updated feedthrough electrical test system.

Current openFDA PMA Record#

Device
Activa Deep Brain Stimulation Therapy System
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S271
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2017-03-23
Decision code
OK30
Date received
2017-03-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
updated feedthrough electrical test system.