SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY
FDA premarket approval P080025/S065 · decided 2014-04-11
Approval details
- PMA number
- P080025
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SNS BOWEL NEUROSTIMULATORS IMPLANTABLE INTERSTIM FAMILY
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2014-03-13
- Decision date
- 2014-04-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- ADDITIONAL IN-PROCESS INSPECTIONS AND TOOLING CHANGES IN THE MANUFACTURING PROCESS OF A COMPONENT OF THE INTERSTIM II NEUROSTIMULATOR, AT THE MEDTRONIC ENERGY AND COMPONENT CENTER.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |