- Device
- Solesta (Injectable Gel)
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S031
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2021-10-27
- Decision code
- APPR
- Date received
- 2021-05-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to implement electronic labeling and changes to the labeling including revised contraindication, new warnings and new precautions.