DEFLUX INJECTABLE GEL
FDA premarket approval P000029/S019 · decided 2007-04-26
Approval details
- PMA number
- P000029
- Supplement
- S019
- Supplement type
- 135 Review Track For 30-Day Notice
- 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
- 2006-09-05
- Decision date
- 2007-04-26
- Days to decision
- 233 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL FOR TWO NEW WATER SYSTEMS (FOR THE PRODUCTION OF PURIFIED WATER (PW) AND FOR WATER FOR INJECTION (WFI)) AND THE EQUIPMENT FOR THE PRODUCTION, STORAGE AND DISTRIBUTION OF PW AND WFI.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |