PMA P100014S026
- Device
- Solesta Injectable Gel
- Applicant
- Palette Life Sciences
- Product code
- LNM
- Decision date
- 2020-10-09
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Approval of labeling changes after the final report for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Solesta Injectable Gel
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S026
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2020-10-09
- Decision code
- APPR
- Date received
- 2020-04-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval of labeling changes after the final report for the post-approval study (PAS) protocol.