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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
Generic NameGlue, surgical, arteries
ApplicantCRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW, GA 30144
PMA NumberP010003
Supplement NumberS006
Date Received07/25/2005
Decision Date04/13/2006
Product Code MUQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR TWO MANUFACTURING SITES: 1) CENTURION STERILIZATION SERVICES, PART OF TRI-STATE HOSPITAL SUPPLY, SALISBURY, NORTH CAROLINA FOR THE STERILIZATION OF BIOGLUE EXTENDER TIPS; AND 2) COMMAND MEDICAL PRODUCTS, ORMOND BEACH, FLORIDA AS A COMPONENT ASSEMBLER.
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