Solesta Injectable Gel
FDA premarket approval P100014/S034 · decided 2023-07-11
Approval details
- PMA number
- P100014
- Supplement
- S034
- 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
- 2023-06-20
- Decision date
- 2023-07-11
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LNM
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Santa Barbara, CA
- Statement
- Replacement of the current inkjet printer used for printing the Unique Device Identifier (UDI) 2D-barcode on the device carton with a new printer and vision system that will print both the UDI 2D-barcode and associated batch information on the device carton.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Barrigel Injectable Gel (K220641) | Palette Life Sciences | 2022-05-26 |