|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||DURASEAL EXACT SPINE SEALANT SYSTEM|
|Classification Name||sealant, dural|
|Supplement Type|| Special Supplement|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a modification to the instructions for use to instruct the surgeon in the best practices in applying the sealant.