InterStim Therapy System, Verify Evaluation System (SNS Bowel Leads)
FDA premarket approval P080025/S160 · decided 2018-06-02
Approval details
- PMA number
- P080025
- Supplement
- S160
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim Therapy System, Verify Evaluation System (SNS Bowel Leads)
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2018-01-05
- Decision date
- 2018-06-02
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for adding an alternate supplier to manufacture the coil components used in the implanted leads of the Deep Brain Stimulator (DBS), Spinal Cord Stimulation (SCS), and Sacral Nerve Stimulation (SNS) devices.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |