|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||normal 180 day track|
|Supplement Reason|| other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for removal of the cmv igg antibody test from the antepartum maternal donor serum testing panel, while continuing to test the maternal donor sera for cmv igm antibodies and the master cell bank for cmv via pcr.