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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 System
Generic NameSealant, dural
ApplicantINTEGRA LIFESCIENCES CORPORATION
311 ENTERPRISE DR.
PLAINSBORO, NJ 08536
PMA NumberP080013
Supplement NumberS019
Date Received05/15/2020
Decision Date08/17/2020
Product Code NQR 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of a silver colorant to the syringe plunger shaft.
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