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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.
DevicePreveLeak Surgical Sealant
Generic NameSealant, polymerizing
ApplicantBaxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
PMA NumberP100030
Supplement NumberS008
Date Received07/03/2017
Decision Date12/21/2017
Product Code NBE 
Docket Number 17M-6971
Notice Date 01/09/2018
Advisory Committee Cardiovascular
Clinical TrialsNCT01957904
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for Preveleak Surgical Sealant. The device is indicated for use in vascular and cardiac reconstructions (excluding application to arterial and venous grafts used in coronary artery bypass graft surgery) to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness