|Trade Name||CELLPAKER PLASMA COLLECTION DEVICE|
|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 design change (removal of the metering knob) to the cellpaker component of the vitagel surgical hemostat system, introduction of a new contract manufacturer located at tegra medical in darthmouth, massachusetts, a change to the packaging materials and sterilization methods for the system component, and the re-branding of the cellpaker component as vitaprep plasma separator.