|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|
|Generic Name||surgical adhesive|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a 10 ml syringe volume; a softer polymer in the piston of the syringe; an alternate supplier for the polyethylene for the cap plug of the entire delivery system product line; and addition of a 10 pack of pouched (4/pouch) standard syring tips.