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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBIOGLUE SURGICAL ADHESIVE
Classification Nameglue,surgical,arteries
Generic Nameglue,surgical,arteries
Applicant
CRYOLIFE, INC.
1655 roberts blvd., n.w.
kennesaw, GA 30144
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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