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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.
 
DeviceSpineSeal Spine Sealant
Generic NameSealant, dural
ApplicantPramand, LLC
201 Burlington Rd., Suite 210
Bedford, MA 02420
PMA NumberP240027
Date Received08/19/2024
Decision Date02/14/2025
Product Code NQR 
Docket Number 25M-0438
Notice Date 02/21/2025
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The SpineSeal Spine Sealant is indicated for use as an adjunct to sutured dural repair during spinal surgery to provide watertight closure.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002  S005 S004 
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