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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 EXTENDED APPLICATOR SPRAY TIP.
Generic NameSealant, polymerizing
ApplicantNEOMEND, INC.
60 TECHNOLOGY DR.
IRVINE, CA 92618
PMA NumberP150016
Supplement NumberS002
Date Received10/19/2016
Decision Date12/19/2016
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  
Addition of alternate suppliers of testing services and reagents for quality testing of the Tridyne Vascular Sealant.
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