DEFLUX INJECTABLE GEL
FDA premarket approval P000029/S006 · decided 2004-03-01
Approval details
- PMA number
- P000029
- Supplement
- S006
- Supplement type
- 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
- 2004-02-12
- Decision date
- 2004-03-01
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- CHANGES IN BIOBURDEN TEST SITE FROM AN EXTERNAL LAB TO IN-HOUSE, AN IDENTITY TEST METHOD FOR A RAW MATERIAL, AND SPECIFICATION LIMITS FOR A RAW MATERIAL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |