FDA.reportPublic FDA data

PMA P960009S374

Device
Activa Deep Brain Stimulation Therapy System
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S374
Product code
MHY
Decision date
2020-05-08
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Approval order statement
Change requested to modify the procedure for the assessment of device bioburden at Medtronic's final device manufacturing facilities-Medtronic Puerto Rico Operations Company, located in Juncos, Puerto Rico .The change also requested other related administrative changes which update the procedure.

Current openFDA PMA Record#

Device
Activa Deep Brain Stimulation Therapy System
Applicant
Medtronic, Inc.
PMA number
P960009
Supplement
S374
Product code
MHY
Generic name
Stimulator, electrical, implanted, for parkinsonian tremor
Decision date
2020-05-08
Decision code
OK30
Date received
2020-04-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change requested to modify the procedure for the assessment of device bioburden at Medtronic's final device manufacturing facilities-Medtronic Puerto Rico Operations Company, located in Juncos, Puerto Rico .The change also requested other related administrative changes which update the procedure.