INTERSTIM SACRAL NERVE STIMULATION SYSTEM
FDA premarket approval P080025/S008 · decided 2011-06-10
Approval details
- PMA number
- P080025
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INTERSTIM SACRAL NERVE STIMULATION SYSTEM
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2011-05-25
- Decision date
- 2011-06-10
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE LABELING FOR THE 3037 PATIENT PROGRAMMER TO ADD NEW PRECAUTIONS RELATING TO MODIFICATION OF THE DEVICE AND THE EFFECT OF ELECTROMAGNETIC INTERFERENCE (EMI) ON THE PATIENT PROGRAMMERS ABILITY TO COMMUNICATE WITH THE NEUROSTIMULATOR.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |