SOLESTA
FDA premarket approval P100014/S004 · decided 2011-10-27
Approval details
- PMA number
- P100014
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SOLESTA
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2011-10-13
- Decision date
- 2011-10-27
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- APPROVAL OF THE POST-APPROVAL PROTOCOL.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |