|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||SAPIEN XT TRANSCATHETER HEART VALVE|
|Classification Name||aortic valve, prosthesis, percutaneously delivered|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Extend the shelf life of the polytetra-fluoroethylene round suture from 5 years to 8 years.