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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
Generic NameSealant, polymerizing
ApplicantNEOMEND, INC.
60 TECHNOLOGY DR.
IRVINE, CA 92618
PMA NumberP150016
Supplement NumberS018
Date Received05/01/2020
Decision Date12/21/2020
Product Code NBE 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the HPLC chromatography column and test method used to evaluate the protein aggregate content in the Human Serum Albumin component of the chemistry kits contained in the PROGEL PALS and TRIDYNE VS finished devices.
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