|Trade Name||EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES|
|Classification Name||aortic valve, prosthesis, percutaneously delivered|
|Applicant||EDWARDS LIFESCIENCES LLC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Expansion of the current manufacturing clean room environment used to manufacture the transcatheter heart valve accessories at the edwards draper, utah facility.