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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDURASEAL EXACT SPINE SEALANT
Generic NameSealant, dural
ApplicantINTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP080013
Supplement NumberS011
Date Received02/02/2015
Decision Date05/11/2015
Product Code NQR 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE FOLLOWING CHANGES TO THE POST-APPROVAL STUDY FOR THE DEVICE:1) CHANGE THE DEFINITION OF THE MINIMUM NECESSARY FOLLOW-UP FROM 60 TO 45 DAYS FOR THE RETROSPECTIVE CONTROL SUBJECTS ONLY; AND 2) ALLOW ANY NEW STUDY SITES THAT DO NOT HAVE 90 DAY STANDARD OF CARE VISITS TO ENROLL PROSPECTIVE SUBJECTS ONLY (DURASEAL AND/OR CONTROL). THIS WOULD ALLOW NEW SITES TO CONTRIBUTE SUBJECTS PROSPECTIVELY INSIDE THE STUDY WINDOW (60 TO 120 DAYS), BUT EXCLUDE RETROSPECTIVE SUBJECTS THAT WOULD POTENTIALLY HAVE BEEN SEEN OUTSIDE OF THE STUDY WINDOW THUS MAINTAINING CONTROL OVER FOLLOW-UP COMPLIANCE.
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