Solesta Injectable Gel
FDA premarket approval P100014/S027 · decided 2020-07-09
Approval details
- PMA number
- P100014
- Supplement
- S027
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Solesta Injectable Gel
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Applicant
- Palette Life Sciences
- Date received
- 2020-06-09
- Decision date
- 2020-07-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- Extension of shelf life for a critical raw material due to a change in secondary packaging and the addition of a quality control specification limit for the raw material .
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 |