Premarket Approval (PMA)

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.

• Trade Name: TITAN INFLATABLE PENILE PROSTHESIS
• Classification Name: device, impotence, mechanical/hydraulic
• Regulation Number: 876.3350
• Applicant: COLOPLAST CORP.
• PMA Number: P000006
• Supplement Number: S025
• Date Received: 07/22/2011
• Decision Date: 08/18/2011
• Product Code: FHW [ Registered Establishments with FHW ]
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: 30-day notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of another supplier of tubing.