|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|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to the pvs patient guide and post-procedure (nursing) guide.