- Device
- InterStim Therapy System and Verify Evaluation System (SNS Urinary)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S330
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2021-03-31
- Decision code
- OK30
- Date received
- 2021-03-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automating the manual process of updating preloaded Data Flash Image (DFI) that manages battery performance for the FOB component.