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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceCGuard Prime Carotid Stent System
Generic NameStent, carotid
ApplicantInspiremd, Ltd.
6303 Waterford District Dr., Suite 215
Miami, FL 33126
PMA NumberP240029
Date Received09/16/2024
Decision Date06/23/2025
Product Code NIM 
Advisory Committee Cardiovascular
Clinical TrialsNCT04900844
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The CGuard Prime Carotid Stent System, when used in conjunction with embolic protection devices specified in the labeling, is indicated for improving carotid luminal diameter in patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet both criteria outlined below:• Patients with neurological symptoms and >=50% stenosis of the common or internal carotid artery by angiogram or patients without neurological symptoms and >=80% stenosis of the common or internal carotid artery by angiogram.• Patients having a vessel with reference diameters between 6.4mm and 9.0 mm at the target lesion.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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