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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 2.5ML AND 5.0 FILL VOLUMES
Generic NameSealant, polymerizing
ApplicantBaxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake, IL 60015
PMA NumberP100030
Supplement NumberS001
Date Received09/03/2013
Decision Date11/25/2013
Product Code NBE 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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