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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCONTIGEN BARD COLLAGEN IMPLANT
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Namecollagen implant for urinary incontinence
ApplicantCOLLAGEN CORP.
PMA NumberP900030
Supplement NumberS005
Date Received11/01/1995
Decision Date03/08/1996
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
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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