SACRAL NERVE STIMULATION- BOWEL IMPLANTABLE NEUROSTIMULATORS
FDA premarket approval P080025/S035 · decided 2012-12-03
Approval details
- PMA number
- P080025
- Supplement
- S035
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SACRAL NERVE STIMULATION- BOWEL IMPLANTABLE NEUROSTIMULATORS
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2012-07-23
- Decision date
- 2012-12-03
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR ADDITION OF THE IN-PROCESS INSPECTION FOR THE CATHOD MIX USED IN BATTERY MODELS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |