|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 AND PROGEL EXTENDED APPLICATOR SPRAY TIP|
|Generic Name||surgical sealant|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| pas protocal supplement osb|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to extend enrollment by 13 months to complete enrollment in the pas to the post-approval study protocol.