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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.
 
DeviceNeuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
Generic NameSTENT, CAROTID
ApplicantContego Medical Inc.
3801 Lake Boone Trail, Suite 100
Raleigh, NC 27607
PMA NumberP240009
Date Received03/29/2024
Decision Date10/11/2024
Product Code NIM 
Advisory Committee Cardiovascular
Clinical TrialsNCT04201132
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
This Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in subjects at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below:• Patients with symptomatic stenosis of the common or internal carotid artery with >=50% as determined by angiography using NASCET methodology, or Patients with asymptomatic stenosis of the common or internal carotid artery with >=80% as determined by angiography using NASCET methodology;• Patients with reference vessel diameters 4.0 – 8.0 mm. This device is also indicated for post-dilation of the stent component with simultaneous capture and removal of embolic material. The Neuroguard IEP System should always be used in conjunction with an available primary distal embolic protection device as described in the IFU.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002  
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