INTERSTIM SYSTEM
FDA premarket approval P080025/S013 · decided 2011-08-25
Approval details
- PMA number
- P080025
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INTERSTIM SYSTEM
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2011-07-12
- Decision date
- 2011-08-25
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A STERILIZATION SITE LOCATED AT STERIGENICS US INC. IN QUEENSBURY, NEW YORK.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |