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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 NumberS005
Date Received04/10/2017
Decision Date07/06/2017
Product Code NBE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to modify the storage conditions of Tridyne Vascular Sealant (Tridyne VS) from refrigerated conditions 2-8°C (36-46°F) to include a controlled ambient temperature storage excursion of 8-25°C (46-77°F) for a period of up to 35 days within the approved shelf life of 24 months.
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