|
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 | S051 |
Date Received | 10/06/2008 |
Decision Date | 10/22/2008 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATION OF THE DEFLUX PACKAGE INSERT TO MINIMIZE THE INCIDENCE OF SYRINGE BREAKAGE AND RESULTING TREATMENT INTERRUPTIONS. |