CGuard Prime Carotid Stent System
FDA premarket approval P240029 · decided 2025-06-23
Approval details
- PMA number
- P240029
- Trade name
- CGuard Prime Carotid Stent System
- Generic name
- Stent, carotid
- Applicant
- InspireMD, Ltd.
- Date received
- 2024-09-16
- Decision date
- 2025-06-23
- Days to decision
- 280 days
- Decision code
- APPR
- Product code
- NIM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami, FL
- 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 th
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