|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||PREVELEAK SURGICAL SEALANT|
|Applicant||TENAXIS MEDICAL, INC.|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| labeling change - trade name|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a product trade name change from arterx® surgical sealant to preveleak surgical sealant. The device, as modified, will be marketed under the trade name preveleak surgical sealant and is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.