FDA.reportPublic FDA data

PMA P080025S232

Device
lnterStim Therapy System, Verify Evaluation System (SNS Bowel)
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S232
Product code
QON
Decision date
2021-08-13
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Approval order statement
Change to the welding process and equipment at external supplier, Bal Seal Engineering (BSE), who supplies Radial Spring Contacts to Medtronic Energy and Component Center (MECC).

Current openFDA PMA Record#

Device
lnterStim Therapy System, Verify Evaluation System (SNS Bowel)
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S232
Product code
QON
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Decision date
2021-08-13
Decision code
OK30
Date received
2021-07-14
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change to the welding process and equipment at external supplier, Bal Seal Engineering (BSE), who supplies Radial Spring Contacts to Medtronic Energy and Component Center (MECC).