|
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 | S021 |
Date Received | 03/05/2007 |
Decision Date | 07/21/2008 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE SOURCE OF DEXTRANOMER MATERIAL USED TO MANUFACTURE DEFLUX INJECTABLE GEL FROM DX-10 TO DX. |
Post-Approval Study | Show Report Schedule and Study Progress |