InterStim Therapy System, Verify Evaluation System
FDA premarket approval P080025/S259 · decided 2023-04-12
Approval details
- PMA number
- P080025
- Supplement
- S259
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System, Verify Evaluation System
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-05-09
- Decision date
- 2023-04-12
- Days to decision
- 338 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for an alternate Sterilization site located at Sterigenics S. De R.L. de C.V., James Watt No. 22, Parque Industrial Cuamatla, Cuautitlan Izcalli Mexico, MX CP 54730 Mexico.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |