|Trade Name|| TITAN INFLATABLE PENILE PROSTHESIS|
|Classification Name||device, impotence, mechanical/hydraulic|
|Applicant||COLOPLAST MANUFACTURING US, LLC|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|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.