|
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 | S012 |
Date Received | 04/08/2005 |
Decision Date | 08/02/2005 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATION OF THE POST APPROVAL STUDY PROTOCOL TO: 1) REPLACE THE 1- AND 5-YEAR VOIDING CYSTOURETHROGRAM MEASUREMENTS WITH CLINICAL ASSESSMENTS OF "FEBRILE UTI;" AND 2) DECREASE THE TOTAL SAMPLE SIZE FROM 200 TO 149 PATIENTS. |