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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namesealant,polymerizing
Generic Namesealant,polymerizing
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[ Registered Establishments with NBE ]
Docket Number 02M-0076
Notice Date 02/25/2002
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003