|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||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifying the storage conditions of progel pleural air leak. The inclusion of a consecutive or cumulative controlled room temperature storage excursion of 8 °c to 25 °c for a period up to 35 days within the approved 24-month shelf life when the device is normally stored between 2 °c to 8°c.