|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 for the introduction of human epidermal keratinocyte cell strain 197 (hep 197) for use in the manufacture of apligraf, and for approval of a change from the current test assay for detection of certain viral contaminants to a real-time pcr method from a conventional gel-based pcr method.