Stent, Carotid
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- PRECISE PRO RX Transcarotid Stent System
- PMA Number
- P030047
- Supplement Number
- S049
- Device Class
- FDA Class 3
- Product Code
- NIM
- Generic Name
- Stent, carotid
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 4, 2025
- Date Received
- October 1, 2024
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
The PRECISE® PRO Transcarotid Stent System used in conjunction with the ENROUTE® Transcarotid Neuroprotection System (NPS), is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the criteria outlined below.1. Patients with neurological symptoms and >= 50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and >= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND2. Patients must have a vessel diameter of 4-9 mm at the target lesion,AND 3. Carotid bifurcation is located at minimum 5cm above the clavicle to allow for placement of the ENROUTE Transcarotid NPS.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NIM | Stent, Carotid | FDA class 3 | Unknown |