PMA P970004
- Device
- InterStim™ Therapy System Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S378
- Product code
- EZW
- Decision date
- 2026-09-14
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- the addition of a manufacturing verification step for the WR9220A and P720R1 wireless rechargers
Current openFDA PMA Record#
- Device
- InterStim™ Therapy System Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S458
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-09-14
- Decision code
- OK30
- Date received
- 2026-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a manufacturing verification step for the WR9220A and P720R1 wireless rechargers