|
Device | DEFLUX INJECTABLE GEL |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | Palette Life Sciences 27 East Cota Street Suite 402 Santa Barbara, CA 93101 |
PMA Number | P000029 |
Supplement Number | S052 |
Date Received | 11/13/2008 |
Decision Date | 12/12/2008 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement BACKUP SUPPLIER TO INCLUDE NEW IN-HOUSE QUALITY CONTROL TESTING FOR A RAW MATERIAL USED IN THE DEFLUX® INJECTABLE GEL MANUFACTURING PROCESS. |
Post-Approval Study | Show Report Schedule and Study Progress |