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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceARTERX SURGICAL SEALANT,
Generic NameSealant, polymerizing
ApplicantBaxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake, IL 60015
PMA NumberP100030
Supplement NumberS002
Date Received09/03/2013
Decision Date11/05/2013
Product Code NBE 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO EXTEND THE SHELF LIFE FOR ARTERX SURGICAL SEALANT FROM 12 MONTHS TO 24 MONTHS WHEN STORED AT2-8C AND TO EXTEND THE SHELF LIFE FOR THE ARTERX DELIVERY TIPS FROM 12 MONTHS TO 42 MONTHS.
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