PMA P100014S017
- Device
- SOLESTA INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S017
- Product code
- LNM
- Decision date
- 2015-01-21
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- APPROVAL FOR PATIENT LABELING CHANGES.
Current openFDA PMA Record#
- Device
- SOLESTA INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S017
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2015-01-21
- Decision code
- APPR
- Date received
- 2014-11-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR PATIENT LABELING CHANGES.