|Trade Name||ALPHA I 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 hydrophilic coating of the device. The device, as modified, will be marketed under the trade name mentor alpha 1 inflatable penile prosthesis with hydrophilic coating and is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.