|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.|
|Classification Name||dressing, wound and burn, interactive|
||General & Plastic Surgery
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of a new cell strain for the production of apligraf (i. E. , hep990), and the replacement of flow cytometric allogenicity and immuno-phenotyping assays used in cell strain characterization with a similar cell purity assay.