|
Device | 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 | S001 |
Date Received | 01/28/2005 |
Decision Date | 02/09/2005 |
Withdrawal Date
|
04/06/2007 |
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 MODIFICATION OF THE LABELING TO REFLECT A NEW DEVICE TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TEGRESS URETHRAL IMPLANT AND IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD). |
Post-Approval Study | Show Report Schedule and Study Progress |