PMA P080025S336
- Device
- InterStim Therapy System; Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S336
- Product code
- QON
- Decision date
- 2025-12-22
- Classification
- Gastroenterology, Urology
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Approval order statement
- replacement of vapor degreasing solvent
Current openFDA PMA Record#
- Device
- InterStim Therapy System; Verify Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P080025
- Supplement
- S336
- Product code
- QON
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Decision date
- 2025-12-22
- Decision code
- OK30
- Date received
- 2025-11-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- replacement of vapor degreasing solvent