|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|
|Generic Name||surgical sealant|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of neomend, incorporated, irvine, california as a second source supplier for the human serum albumin (hsa) protein cartridges for the device.