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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 NumberS010
Date Received11/29/2017
Decision Date09/12/2018
Product Code NBE 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for alternate sterilization sites located at Bard Regional Sterilization, 1211 Mary Magnum Boulevard, Madison, Georgia and Bard Regional Sterilization, 8195 Industrial Boulevard, Covington, Georgia.
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