- Device
- InterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S334
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2025-11-26
- Decision code
- APPR
- Date received
- 2025-10-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a manufacturing site change to add Medtronic Puerto Rico Operations Company, Villalba facility (MVC) as an alternate sterilization site for Neuromodulation/Pelvic Health (NMPH) Implantable Neurostimulators (INS), Drug Delivery Infusion Pumps (SynchroMed), Catheters and Accessories