|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||PROSTAR TM 8FR AND 10FR PVS AND PROSTAR XL|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes tot he precautions and clinical procedure sections of the instructions for use.