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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 IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)
Generic NameGlue, surgical, arteries
ApplicantCRYOLIFE, INC.
1655 ROBERTS BLVD., N.W.
KENNESAW, GA 30144
PMA NumberP010003
Supplement NumberS003
Date Received03/17/2004
Decision Date05/03/2004
Product Code MUQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DISPOSABLE DUAL-BARREL PISTON-DRIVEN SYRINGE DISPENSING SYSTEM AS AN ALTERNATE TO THE CURRENT DUAL-BARREL REUSABLE RATCHETING PISTON-DRIVEN CARTRIDGE SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BG3500 AND 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).
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