|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||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the replacement of the current duraseal spine sealant polyethylene glycol (peg) formulation with a lower molecular weight formulation.