|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||NEOMEND PROGEL PLEURAL AIR LEAK SEALANT|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the progel applicator extended spray tips as an accessory for the progel pleural air leak sealant. The device, as modified, will be marketed under the trade name progel applicator extended spray tips and the indications for use is to deliver progel to visceral pleura during an open thoracotomy after standard visceral pleural closure (i. E. With sutures or staples) of visible air leaks (>= 2 mm) incurred during open resection of lung parenchyma in adult humans by bending the malleable tip to direct progel from the delivery tip in a stream or spray cone pattern that is perpendicular to the target surface.
|Post-Approval Study||Show Report Schedule and Study Progress|