|Trade Name||PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS|
|Classification Name||device, hemostasis, vascular|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Reclassification of the cleanroom from class 10,000 of the federal standard 209e to class 8 of iso 14644-1 used in the manufacture of the prostar and closure suture-mediated closure systems.