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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NameDURASEAL EXACT SPINE SEALANT SYSTEM
Classification Namesealant, dural
ApplicantCOVIDIEN
PMA NumberP080013
Supplement NumberS003
Date Received01/20/2010
Decision Date02/18/2011
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the replacement of the current duraseal spine sealant polyethylene glycol (peg) formulation with a lower molecular weight formulation.
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