|Trade Name||MENTOR TITAN INFLATABLE PENILE PROSTHESIS|
|Classification Name||device, impotence, mechanical/hydraulic|
|Generic Name||inflatable penile prosthesis|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for reprocessing final, sterilized alpha i inflatable penile prostheses to incorporate the hydrophilic coating that was previously approved for use on newly manufactured prostheses in supplement 1. The device, as modified, will be marketed under the trade name mentor titan inflatable penile prosthesis and is indicated for male patients suffering from erectile dysfunction (impotence) who are considered candidates for implantation of a penile prosthesis.