|Trade Name||VITAPREP PLASMA SEPERATOR|
|Classification Name||agent, absorbable hemostatic, collagen based|
||General & Plastic Surgery
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following two changes to the labeling instructions for use for the vitaprep plasma separator: 1) inclusion of warning statement: "always wear well fitting gloves when handling vitaprep¿ and 2) inclusion of instructions: "assure there is no blood in the luer connection. If blood is present, carefully clear the area of residual blood. ¿.