InterStim Therapy System and Verify Evaluation System (SNS Bowel)
FDA premarket approval P080025/S191 · decided 2019-08-22
Approval details
- PMA number
- P080025
- Supplement
- S191
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System and Verify Evaluation System (SNS Bowel)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2019-07-29
- Decision date
- 2019-08-22
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Implementation of process controls for Soft Straight-Line Finish (SLF) cosmetic rework at Medtronics final device manufacturing facilities-Medtronic Puerto Rico Operations Company (MPROC), located in Juncos, Puerto Rico.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |