|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||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for 1) adding an additional vendor, domnick hunter, plc, for the 0. 2 um-filter to filter bulk component solutions, and 2) adding a solution mixing system for the bovine serum albumin bulk solution for bags up to 20l in capacity.