Deflux® Injectable Gel
FDA premarket approval P000029/S098 · decided 2024-05-31
Approval details
- PMA number
- P000029
- Supplement
- S098
- 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
- 2024-05-01
- Decision date
- 2024-05-31
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- For labeling changes including addition of new safety information in the instructions for use (IFU), exterior packaging, and parent/caregiver brochure
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |