DEFLUX INJECTABLE GEL
FDA premarket approval P000029/S074 · decided 2013-05-22
Approval details
- PMA number
- P000029
- Supplement
- S074
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- DEFLUX INJECTABLE GEL
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2013-04-25
- Decision date
- 2013-05-22
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL FOR UPDATE TO THE INFORMATION ABOUT POST-APPROVAL ADVERSE REACTIONS AND UPDATE ON THE LABELING OF THE SPONSOR NAME AND CONTACT INFORMATION.
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 |