SNS Bowel Neurostimulator/Implantable InterStim
FDA premarket approval P080025/S308 · decided 2024-12-12
Approval details
- PMA number
- P080025
- Supplement
- S308
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SNS Bowel Neurostimulator/Implantable InterStim
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2024-11-14
- Decision date
- 2024-12-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- to allow supplier Mier Tool & Engineering Inc as an alternate supplier to provide the closing buttons for Medtronic Energy and Component Center (Located in Brooklyn Center, MN).
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 |