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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 NameBIOGLUE SURGICAL ADHESIVE
Classification Nameglue,surgical,arteries
Generic Namesurgical adhesive
ApplicantCRYOLIFE, INC.
PMA NumberP010003
Date Received02/02/2001
Decision Date12/03/2001
Product Code
MUQ[ Registered Establishments with MUQ ]
Docket Number 01M-0567
Notice Date 12/20/2001
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 bioflue surgical adhesive. This device is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral and carotid arteries).
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 
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