SOLESTA
FDA premarket approval P100014/S009 · decided 2014-01-14
Approval details
- PMA number
- P100014
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- SOLESTA
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2013-04-01
- Decision date
- 2014-01-14
- Days to decision
- 288 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL FOR THE REVISION OF THE PRESCRIBING INFORMATION TO INCLUDE 24 AND 26 MONTH DATA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |