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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 IN SYRINGE DELIVERY SYSTEM (MODEL BG3500)
Classification Nameglue,surgical,arteries
Generic Namesurgical adhesive
ApplicantCRYOLIFE, INC.
PMA NumberP010003
Supplement NumberS003
Date Received03/17/2004
Decision Date05/03/2004
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
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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