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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameARTERX SURGICAL SEALANT
Classification Namesealant,polymerizing
ApplicantTENAXIS MEDICAL, INC.
PMA NumberP100030
Date Received07/27/2010
Decision Date03/01/2013
Product Code
NBE[ Registered Establishments with NBE ]
Docket Number 13M-0281
Notice Date 03/14/2013
Advisory Committee Cardiovascular
Clinical Trials NCT00759681
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the arterx surgical sealant. This device is indicated for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Approval Order Approval Order
Supplements: S001 S002 S004 
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