|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||normal 180 day track no user fee|
|Supplement Reason|| location change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for two manufacturing sites: 1) centurion sterilization services, part of tri-state hospital supply, salisbury, north carolina for the sterilization of bioglue extender tips; and 2) command medical products, ormond beach, florida as a component assembler.