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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCraniSeal Dural Sealant
Generic NameSealant, dural
ApplicantPramand, LLC
201 Burlington Road, Suite 210
Bedford, MA 01730
PMA NumberP220014
Date Received09/02/2022
Decision Date07/06/2023
Product Code NQR 
Docket Number 23M-3158
Notice Date 07/28/2023
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the CraniSeal Dural Sealant. The device is indicated for use in patients >= 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide watertight closure.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S002 S001 
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