|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||CLOSER (TM) SUTURE MEDIATED CLOSURE DEVICE|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||real-time process|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a manufacturing modification to the foot component of the closer(tm) smc device.