Solesta (Injectable Gel)
FDA premarket approval P100014/S031 · decided 2021-10-27
Approval details
- PMA number
- P100014
- Supplement
- S031
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Solesta (Injectable Gel)
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2021-05-03
- Decision date
- 2021-10-27
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- Approval to implement electronic labeling and changes to the labeling including revised contraindication, new warnings and new precautions.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |