PMA P080025S319
- Device
- InterStim TM Therapy System, Verify ™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S319
- Product code
- QON
- Decision date
- 2026-01-20
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- the use of a new manufacturing material
Current openFDA PMA Record#
- Device
- InterStim TM Therapy System, Verify ™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S319
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2026-01-20
- Decision code
- APPR
- Date received
- 2025-05-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the use of a new manufacturing material