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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
Classification Namesealant, dural
ApplicantINTEGRA LIFESCIENCES CORPORATION
PMA NumberP080013
Supplement NumberS011
Date Received02/02/2015
Decision Date05/11/2015
Product Code
NQR[ Registered Establishments with NQR ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
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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