Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTEGRESS URETHRAL IMPLANT
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantC.R. Bard, Inc.
13183 HARLAND DRIVE
COVINGTON, GA 30014-6421
PMA NumberP030030
Supplement NumberS001
Date Received01/28/2005
Decision Date02/09/2005
Withdrawal Date 04/06/2007
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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).
-
-