|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||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
The 30-day notice requested a manufacturing process change. The requested change will place into the manufacturing process the final 3 production-scale incubators manufactured by lunaire corporation (model #ci0641w-6spl).