PMA P970004S424
- Device
- InterStim TM Therapy System, Verify ™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S424
- Product code
- EZW
- Decision date
- 2026-01-20
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, electrical, implantable, for 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
- P970004
- Supplement
- S424
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for 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