|Trade Name||EDWARDS SAPIEN TRANSCATHETER HEART VALVE|
|Classification Name||aortic valve, prosthesis, percutaneously delivered|
|Applicant||EDWARDS LIFESCIENCES LLC.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for implementation of more detailed crimper manufacturing instructions and additional quality control steps to enhance the safety of the crimper devices.