|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 S(TM) 6FR. SMC DEVICE|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the closer s(tm) 6 fr. Suture mediated closure (smc) system. The device, as modified, is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic catheterization procedures using 5 to 6 fr. Sheaths. The closer s(tm) 6 fr. Suture mediated closure (smc) system reduces the times to hemostasis, ambulation (5 meters or 16 feet) and discharge in patients who have undergone diagnostic catheterization procedures without complicating clinical conditions (refer to precautions, special patient populations in the device labeling).