TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT
FDA premarket approval P080025/S051 · decided 2013-10-22
Approval details
- PMA number
- P080025
- Supplement
- S051
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TEST STIMULATION LEAD BULK ACCESSORY,TEST STIMULATION LEAD KIT
- Generic name
- Implanted electrical device intended for treatment of fecal incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2013-04-26
- Decision date
- 2013-10-22
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- QON
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR CHANGES TO THE LABELING AND PRODUCT SPECIFICATION RELATED TO THE USE OF DIAGNOSTIC ULTRASOUND IMAGING TO HELP GUIDE THE INSERTION OF THE FORAMEN NEEDLE INTO ONE OF THE SACRAL FORAMINA DURING THE ACUTE TEST STIMULATION PROCEDURE.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |