PMA P080025S342

Device: InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Implantable Neurostimulators 97800, 97810)
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S342
Product code: QON
Decision date: 2026-04-03
Classification: Gastroenterology, Urology
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: approval for an update to the equipment used to perform final functional testing on Medtronic Neuromodulation and Pelvic Health implantable devices

Current openFDA PMA Record#

Device: InterStim™ Therapy System, Verify™ Evaluation System (SNS Bowel Implantable Neurostimulators 97800, 97810)
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S342
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2026-04-03
Decision code: OK30
Date received: 2026-03-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an update to the equipment used to perform final functional testing on Medtronic Neuromodulation and Pelvic Health implantable devices