PMA P100014S018
- Device
- SOLESTA INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S018
- Product code
- LNM
- Decision date
- 2017-04-07
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- Approval for a new supplier for the 0.9% NaCl raw material.
Current openFDA PMA Record#
- Device
- SOLESTA INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S018
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2017-04-07
- Decision code
- APPR
- Date received
- 2016-09-12
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a new supplier for the 0.9% NaCl raw material.