|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|| design change - minor|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the push rod (c-00286), end cap (c-00280) and outer housing (c-00279) components of the applicator kit and associated minor labeling changes.