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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameARTERX SURGICAL SEALANT,
Classification Namesealant,polymerizing
ApplicantTENAXIS MEDICAL, INC.
PMA NumberP100030
Supplement NumberS002
Date Received09/05/2013
Decision Date11/05/2013
Product Code
NBE[ Registered Establishments with NBE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product 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.
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