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: COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS
• Generic Name: Device, impotence, mechanical/hydraulic
• Regulation Number: 876.3350
• Applicant: Coloplast Corp.; 1601 W. River Rd. N.; Plymouth, MN 55411
• PMA Number: P000006
• Supplement Number: S010
• Date Received: 04/25/2008
• Decision Date: 08/22/2008
• Product Code: FHW
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No