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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 SPINE SEALANT SYSTEM (DURASEAL EXACT SPINE SEALANT SYSTEM)
Classification Namesealant, dural
ApplicantCOVIDIEN
PMA NumberP080013
Supplement NumberS004
Date Received03/02/2011
Decision Date09/29/2011
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a manufacturing site located at covidien, lp in north haven, connecticut.
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