DEFLUX Injectable Gel
FDA premarket approval P000029/S093 · decided 2020-12-18
Approval details
- PMA number
- P000029
- Supplement
- S093
- 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
- 2020-12-04
- Decision date
- 2020-12-18
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- to modify the microbiological control set sampling plan in accordance with ISO 146981:2003 by replacing batch-related air sample testing to air sampling testing twice a month is acceptable
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |