PMA P100014S016
- Device
- SOLESTA INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S016
- Product code
- LNM
- Decision date
- 2014-10-10
- Classification
- Agent, Bulking, Injectable For Gastro-urology Use
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Approval order statement
- CHANGES TO THE ENVIRONMENTAL LIMITS OF THE CLEAN ROOMS USED DURING SOLESTA MANUFACTURING.
Current openFDA PMA Record#
- Device
- SOLESTA INJECTABLE GEL
- Applicant
- Palette Life Sciences
- PMA number
- P100014
- Supplement
- S016
- Product code
- LNM
- Generic name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
- Decision date
- 2014-10-10
- Decision code
- OK30
- Date received
- 2014-09-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE ENVIRONMENTAL LIMITS OF THE CLEAN ROOMS USED DURING SOLESTA MANUFACTURING.