|Trade Name||COLLAGRAFT STRIP BONE GRAFT MATRIX|
|Classification Name||filler, bone void, non-osteoinduction|
|Generic Name||collagen/hydroxyapatite bone graft substitute|
|Supplement Type||real-time process|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for changes to your manufacturing process. These changes involve 1) moving some of the manufacturing operations currently performed in a class 100 room to a "controlled" environment that provides the equivalent of a class 10,000 environment, 2) increasing the "hold" time between the remisturization and irradiation processes, and 3) eliminating both the protein concentration assay for past homogenate mixing and the lal pyrogenicity assay, as described in the supplement.