PMA P080025S353

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S353
Product code: QON
Decision date: 2026-10-09
Classification: Gastroenterology, Urology
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: approval for the introduction of a second Medium Rate (MR) Header’s manufacturing line (MR Line 2) and to make inspection updates to the MR Headers Line that is currently in production at Medtronic Energy and Components Center (MECC), Brooklyn Center, MN.

Current openFDA PMA Record#

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S353
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2026-10-09
Decision code: OK30
Date received: 2026-09-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the introduction of a second Medium Rate (MR) Header’s manufacturing line (MR Line 2) and to make inspection updates to the MR Headers Line that is currently in production at Medtronic Energy and Components Center (MECC), Brooklyn Center, MN.