PMA P970004S457
- Device
- InterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S457
- Product code
- EZW
- Decision date
- 2026-10-06
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- a new stand-alone torque wrench kit configuration (Model B31020-T)
Current openFDA PMA Record#
- Device
- InterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S457
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-10-06
- Decision code
- APPR
- Date received
- 2026-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- a new stand-alone torque wrench kit configuration (Model B31020-T)