DEFLUX
FDA premarket approval P000029/S013 · decided 2005-12-12
Approval details
- PMA number
- P000029
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DEFLUX
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2005-06-06
- Decision date
- 2005-12-12
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL FOR PERFORMING THE PROTEIN TESTING IN-HOUSE AT THE Q-MED QUALITY CONTROL LABORATORY AND TO CHANGE THE TEST METHOD SO AS TO ALLOW FOR THE DETECTION OF LOWER AMOUNTS OF PROTEIN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEFLUX AND IS INDICATED FOR THE TREATMENT OF VESICOURETERAL REFLUX IN CHILDREN.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |