|
Device | CONTIGEN BARD COLLAGEN IMPLANT |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | Allergan, Inc. 71 SOUTH LOS CARNEROS ROAD GOLETA, CA 93111 |
PMA Number | P900030 |
Supplement Number | S009 |
Date Received | 06/13/2005 |
Decision Date | 09/21/2006 |
Withdrawal Date
|
10/25/2011 |
Product Code |
LNM |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDE INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT B. |