|Trade Name||VITAGEL SURGICAL HEMOSTAT|
|Classification Name||agent, absorbable hemostatic, collagen based|
||General & Plastic Surgery
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new version of vitagel where the bovine thrombin component is replaced with recombinant human thrombin. The product, as modified, will be marketed under the trade name vitagel rt and is indicated in surgical procedures (other than neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.