|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||TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS|
|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 to expand the range of users of the prostar(r) and techstar(r) pvs systems to inlcude healthcare professionals other than physicians.