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.
 
DeviceCONTIGEN BARD COLLAGEN IMPLANT
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantAllergan, Inc.
71 SOUTH LOS CARNEROS ROAD
GOLETA, CA 93111
PMA NumberP900030
Supplement NumberS011
Date Received03/03/2009
Decision Date10/02/2009
Withdrawal Date 10/25/2011
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISED DIRECTIONS FOR USE (DFU) THAT INCLUDES INFORMATION FROM THE POST-APPROVAL STUDY ON COHORT C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTIGEN BARD COLLAGEN IMPLANT AND IS INDICATED FOR USE ONLY IN THE TREATMENT OF URINARY INCONTINENCE DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD, POOR OR NONFUNCTIONING BLADDER OUTLET MECHANISM) THAT MAY BE HELPED BY A LOCALLY INJECTED BULKING AGENT. CONTIGEN IMPLANT THERAPY SHOULD BE INITIATED ONLY IN PATIENTS WHO HAVE SHOWN NO IMPROVEMENT IN THEIR INCONTINENCE FOR AT LEAST 12 MONTHS.
-
-