|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||PERCLOSE PROSTAR XL 10 FRENCH PVS SYSTEM|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modified percutaneous vascular surgical (pvs) system. The device, as modified, will be marketed under the trade name prostar(r) xl 10 french percutaneous vascular surgical (pvs) system and is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site and reducing the time to hemostasis and ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 8. 5f to 10f sheaths.