|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||ARTERX SURGICAL SEALANT,|
|Applicant||TENAXIS MEDICAL, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - shelf-life|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to extend the shelf life for arterx surgical sealant from 12 months to 24 months when stored at 2-8c and to extend the shelf life for the arterx delivery tips from 12 months to 42 months.