|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 XL SUTURE MEDIATED CLOSURE (SMC) SYSTEM|
|Classification Name||device, hemostasis, vascular|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||normal 180 day track|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for various dimensional changes which result in a larger version of the original device. The device, as modified, will be marketed under the trade name closer xl suture mediated closure (smc) system and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access sites of patients who have undergone diagnostic and interventional catheterization procedures using 8 fr sheaths.