InterStim® Therapy System, Verify® Evaluation System (SNS Bowel)
FDA premarket approval P080025/S266 · decided 2022-07-28
Approval details
- PMA number
- P080025
- Supplement
- S266
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim® Therapy System, Verify® Evaluation System (SNS Bowel)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-07-20
- Decision date
- 2022-07-28
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Change to the Ionograph Out-of-Control Action Plan (OCAP) and the test sampling plan within the Final Clean process for hybrids manufactured at Medtronic Tempe Campus (MTC).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |