InterStim Therapy System. Verify Evaluation System
FDA premarket approval P080025/S151 · decided 2018-04-13
Approval details
- PMA number
- P080025
- Supplement
- S151
- 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
- 2017-09-05
- Decision date
- 2018-04-13
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a manufacturing site located at Road 31, Km. 24, Hm 4, Ceiba Norte Industrial Park, Juncos, Puerto Rico 00777, for kitting activities including Sterile Packaging, Sterilization, Final Pack & Label, and Final QA Inspection.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |