|Trade Name||CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS|
|Classification Name||replacement heart-valve|
|Generic Name||heart valve for mitral valve replacement|
|Applicant||EDWARDS LIFESCIENCES, LLC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
An increase in the number of hepa filters in a gowning room and the addition of corresponding hand dryers, and remodeling of a transfer room to include an emergency exit corridor and emergency exit door.