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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.
Classification Nameglue,surgical,arteries
Generic Nameglue,surgical,arteries
1655 roberts blvd., n.w.
kennesaw, GA 30144
PMA NumberP010003
Supplement NumberS005
Date Received04/14/2005
Decision Date01/20/2006
Product Code
MUQ[ Registered Establishments with MUQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) addition of two spreader tips, size 12 mm and 16 mm; 2) addition of a green colorant (fda 21 cfr 178. 3297 compliant mbpp 11962) to the collar of the mixing tip for easier visualization of the mating mechanism; 3) modification (blunting the end rather than pointed tip) of the mixing chamber stem end to accept the new applicator tips; 4) modification of the collar formulation for the polypropylene; 5) use of a new material for the spreader extension; and 6) modification of the stem material.