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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.
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Namecollagen implant for urinary incontinence
PMA NumberP900030
Supplement NumberS011
Date Received03/03/2009
Decision Date10/02/2009
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
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.