PMA P080025S344

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S344
Product code: QON
Decision date: 2026-05-01
Classification: Gastroenterology, Urology
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Approval for updates to the software programs on the Medium Rate battery line at Medtronic supplier, Medtronic Energy and Component Center (MECC).

Current openFDA PMA Record#

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S344
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2026-05-01
Decision code: OK30
Date received: 2026-04-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for updates to the software programs on the Medium Rate battery line at Medtronic supplier, Medtronic Energy and Component Center (MECC).