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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 supplement. The device description may have changed. Be sure to look at the original PMA 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
Supplement NumberS007
Date Received10/31/2005
Decision Date12/08/2005
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a 10 ml syringe volume; a softer polymer in the piston of the syringe; an alternate supplier for the polyethylene for the cap plug of the entire delivery system product line; and addition of a 10 pack of pouched (4/pouch) standard syring tips.
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