|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|
|Supplement Type||real-time process|
|Supplement Reason|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following modifications to the titan narrow base cylinder (11 and 14 cm lengths only): (i) change of the angle of the tubing from 22. 5° to 0°, and (ii) change in cylinder tip material from dipped-on bioflex to bonded-on med 4750.