FDA.reportPublic FDA data

PMA P080025S231

Device
InterStim Therapy System, Verify Evaluation System (SNS Bowel)
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S231
Product code
QON
Decision date
2021-07-15
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Approval order statement
Use additional existing sealer tray machines and to update applicable procedures to include validated sealing and peel strength testing parameters on the Sterile Pack Manufacturing Line.

Current openFDA PMA Record#

Device
InterStim Therapy System, Verify Evaluation System (SNS Bowel)
Applicant
Medtronic Neuromodulation
PMA number
P080025
Supplement
S231
Product code
QON
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Decision date
2021-07-15
Decision code
OK30
Date received
2021-07-08
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use additional existing sealer tray machines and to update applicable procedures to include validated sealing and peel strength testing parameters on the Sterile Pack Manufacturing Line.