SOLESTA
FDA premarket approval P100014/S006 · decided 2012-05-04
Approval details
- PMA number
- P100014
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOLESTA
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2012-03-23
- Decision date
- 2012-05-04
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- ADDITIONAL LABORATORY FOR ANALYTICAL TESTING
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| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |