Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
• Generic Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Applicant: Allergan, Inc.; 71 S. Los Carneros Rd.; Goleta, CA 93111
• PMA Number: P900030
• Date Received: 04/27/1990
• Decision Date: 09/30/1993
• Withdrawal Date: 10/25/2011
• Product Code: LNM
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for the Contigen™ Bard® Collagen Implant. This device is indicated for use in the treatment of urinary incontinence due to intrinsic sphincter deficiency (poor or non-functioning bladder outlet mechanism) that may be helped by a locally injected bulking agent. Contigen implant therapy is intended only for patients who have shown no improvement in their incontinence for at least 12 months.

• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S009 S010 S011