INTERSTIM THERAPY SYSTEMS
FDA premarket approval P080025/S016 · decided 2012-04-10
Approval details
- PMA number
- P080025
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTERSTIM THERAPY SYSTEMS
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2011-07-25
- Decision date
- 2012-04-10
- Days to decision
- 260 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR UPDATING THE LABELING TO ALLOW PARTICULAR TYPES OF MRI SCANS TO BE PERFORMED WHILE THE DEVICES ARE IMPLANTED AND FOR ASSOCIATED CHANGES IN THE PRODUCT SPECIFICATION OF MODEL 3023 INTERSTIM NEUROSTIMULATOR.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |