|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 8 & 10 FRENCH PVS SYSTEM|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an additional effectiveness claim (i. E. , reduced time to discharge) for the prostar(r) xl 8f percutaneous vascular surgical (pvs) system. The device will be marketed under the trade name prostar(r) xl 8f percutaneous vascular surgical (pvs) system and is now indicated for: "the percutaneous delivery of sutures for closing the common femoral artery access site and reducing time to hemostasis and time to ambulation (patient walks ten feet) of patients who have undergone catheterization procedures using 6. 5 fr. To 8 fr. Sheaths. The prostar xl 8 fr. System reduces the time to discharge in patients having undergone diagnostic catheterization procedures without complicating clinical conditions (refer to precautions, special patient populations). ".