MEDTRONIC INTERSTIM SACRAL NERVE THERAPY SYSTEM
FDA premarket approval P080025/S020 · decided 2011-09-06
Approval details
- PMA number
- P080025
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC INTERSTIM SACRAL NERVE THERAPY SYSTEM
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2011-08-10
- Decision date
- 2011-09-06
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MINOR DESIGN, MANUFACTURING, AND LABELING CHANGES TO THE MODEL 3625 EXTERNAL TEST STIMULATOR IN ORDER TO ESTABLISH COMPLIANCE WITH FUNCTIONAL REQUIREMENTS IN THE HARMONIZED STANDARDS IEC (INTERNATIONAL ELECTROTECHNICAL COMMISSION) 60601-1 AND IEC 60601-1-2.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |