|Trade Name|| TITAN INFLATABLE PENILE PROSTHESIS|
|Classification Name||device, impotence, mechanical/hydraulic|
|Generic Name||device, impotence, mechanical/hydraulic|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new device production mold that incorporates a tear trim and strain relief feature, as well as modifications to associated engineering drawings and dimensional tolerance specifications.