|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 2.5ML AND 5.0 FILL VOLUMES|
|Applicant||TENAXIS MEDICAL, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of 2. 5ml and 5. 0ml fill volumes to the existing 4. 0ml fill volume, using the same 5ml syringe and packaging.