|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.|
|Trade Name||PROGEL PLEURAL AIR LEAK SEALANT|
|Generic Name||surgical sealant|
|Supplement Type||normal 180 day track|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the shipping temperature range to 1ºc to 30°c to allow for brief possible extremes in temperature during shipment. The agency notes that the "keep refrigerated" label, c-00473, will be affixed to the shipping container.