DEFLUX INJECTABLE GEL
FDA premarket approval P000029/S011 · decided 2004-11-12
Approval details
- PMA number
- P000029
- Supplement
- S011
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- DEFLUX INJECTABLE GEL
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2004-10-28
- Decision date
- 2004-11-12
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL FOR AN INCREASE IN THE SHELF LIFE OF DX-10 FROM 6 MONTHS TO 12 MONTHS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |