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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.
 
Trade NameCOSEAL SURGICAL SEALANT (COSEAL)
Classification Namesealant,polymerizing
Generic Namesurgical sealant
ApplicantANGIOTECH MEDICAL DEVICE TECHNOLOGIES
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 
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