- Device
- InterStim Therapy System and Verify Evaluation System (SNS Urinary)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S331
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2021-04-06
- Decision code
- OK30
- Date received
- 2021-03-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the Implantable Neurostimulator (INS) devices weld monitoring method from a manual peel test to an automated pull test.