PMA P100014S009
- Device
- SOLESTA
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S009
- Product code
- LNM
- Decision date
- 2014-01-14
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR THE REVISION OF THE PRESCRIBING INFORMATION TO INCLUDE 24 AND 26 MONTH DATA.
Current openFDA PMA Record#
- Device
- SOLESTA
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S009
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2014-01-14
- Decision code
- APPR
- Date received
- 2013-04-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR THE REVISION OF THE PRESCRIBING INFORMATION TO INCLUDE 24 AND 26 MONTH DATA.