PMA P080025S349

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S349
Product code: QON
Decision date: 2026-06-16
Classification: Gastroenterology, Urology
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Replacement of the existing laser cutting workstation used in the manufacturing process of Lithium-Ion Intellis and Perficio batteries for Medtronic Neuromodulation devices.

Current openFDA PMA Record#

Device: InterStim™ Therapy System, Verify™ Evaluation System
Applicant: Medtronic Neuromodulation
PMA number: P080025
Supplement: S349
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2026-06-16
Decision code: OK30
Date received: 2026-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the existing laser cutting workstation used in the manufacturing process of Lithium-Ion Intellis and Perficio batteries for Medtronic Neuromodulation devices.