|Trade Name||CONTIGEN BARD COLLAGEN IMPLANT|
|Classification Name||agent, bulking, injectable for gastro-urology use|
|Generic Name||collagen implant for urinary incontinence|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling for post approval study|
|Expedited Review Granted?|| 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.