PMA P970004
- Device
- InterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S378
- Product code
- EZW
- Decision date
- 2026-08-14
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Approval order statement
- implementation of manufacturing controls for Intellis rechargeable lithium-ion batteries.
Current openFDA PMA Record#
- Device
- InterStim™ Therapy System, Verify™ Evaluation System
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S456
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2026-08-14
- Decision code
- OK30
- Date received
- 2026-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of manufacturing controls for Intellis rechargeable lithium-ion batteries.