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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.
 
DeviceTRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip
Generic NameSealant, polymerizing
ApplicantNEOMEND, INC.
60 TECHNOLOGY DR.
IRVINE, CA 92618
PMA NumberP150016
Supplement NumberS007
Date Received11/28/2017
Decision Date12/20/2017
Product Code NBE 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Changes to the processing of the Human Serum Albumin (HSA) and Polyethylene Glycol (PEG) components of the Tridyne Vascular Sealant.
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