|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 Name||BIOGLUE SURGICAL ADHESIVE|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| 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.