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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 S. Los Carneros Rd.
Goleta, CA 93111
PMA NumberP900030
Supplement NumberS005
Date Received11/01/1995
Decision Date03/08/1996
Withdrawal Date10/25/2011
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR:1) MARKETINGTHE CURRENT CONTIGEN IMPLANT PRODUCT LINE IN A MODIFIED PACKAGING CONFIGURATION INSTEAD OF THE CURRENT CONFIGURATION, 2)CHANGING THE LOCATION OF THE SKINT TEST PACKAGING OPERATIN FROM COLLAGEN CORP, FREMONT, CA, TO BARD UROLOGICAL DIV, COVINGTON, GA 3)REVISING THE WARNING STATEMENT REGARDING CONNECTIVE TISSUE DISEASE IN THE PACKAGE INSERTS, PATIENT BROCHURES AND SAFETY SUMMARIES, AND 4)UPDATING THE PATIENT RECORD AND SKIN TEST CARD LABELING
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