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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCOSEAL SURGICAL SEALANT (COSEAL)
Generic NameSealant, polymerizing
ApplicantANGIOTECH MEDICAL DEVICE TECHNOLOGIES
3600 S.W 47TH AVENUE
GAINESVILLE, FL 32608
PMA NumberP010022
Date Received04/12/2001
Decision Date12/14/2001
Withdrawal Date 03/15/2012
Product Code NBE 
Docket Number 02M-0076
Notice Date 02/25/2002
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE COSEAL SURGICAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S003 S002 
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