DEFLUX INJECTABLE GEL
FDA premarket approval P000029/S021 · decided 2008-07-21
Approval details
- PMA number
- P000029
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DEFLUX INJECTABLE GEL
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2007-03-05
- Decision date
- 2008-07-21
- Days to decision
- 504 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL FOR A CHANGE IN THE SOURCE OF DEXTRANOMER MATERIAL USED TO MANUFACTURE DEFLUX INJECTABLE GEL FROM DX-10 TO DX.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |