|Trade Name||MITRACLIP CLIP DELIVERY SYSTEM|
|Classification Name||mitral valve repair devices|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a labeling change that included additions to the list of anticipated events and converting certain procedural caution statements to warning statements.