- Device
- InterStim Therapy System and Verify Evaluation System (SNS Urinary)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P970004
- Supplement
- S316
- Product code
- EZW
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Decision date
- 2020-10-01
- Decision code
- OK30
- Date received
- 2020-09-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of Innovizes sheet-converting manufacturing area from 500 Oak Grove Parkway to 450 Oak Grove Parkway.