|
Device | BARD TEGRESS URETHRAL IMPLANT |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | C.R. Bard, Inc. 13183 HARLAND DRIVE COVINGTON, GA 30014-6421 |
PMA Number | P030030 |
Supplement Number | S003 |
Date Received | 08/29/2005 |
Decision Date | 05/23/2006 |
Withdrawal Date
|
04/06/2007 |
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 MODIFICATIONS TO THE POSTAPPROVAL STUDY PROTOCOL. |
Post-Approval Study | Show Report Schedule and Study Progress |