Premarket Approval (PMA)

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.

• Device: BARD TEGRESS URETHRAL IMPLANT
• Generic Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Applicant: C.R. Bard, Inc.; 13183 Harland Dr.; Covington, GA 30014
• PMA Number: P030030
• Supplement Number: S002
• Date Received: 05/04/2005
• Decision Date: 05/27/2005
• Withdrawal Date: 04/06/2007
• Product Code: LNM
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track No User Fee
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE AT BARD SHANNON LTD., LAS PIEDRAS, PUERTO RICO, 00771.