Stent, Carotid
Basic Information
- Device Name
- Stent, Carotid
- Trade Name
- Roadsaver/CASPER Carotid Stent Device
- PMA Number
- P210030
- 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
- November 20, 2024
- Date Received
- July 28, 2021
- Expedited Review
- N
Advisory Committee Statement
Approval for the Roadsaver (or CASPER) Carotid Stent System, when used in conjunction with the Nanoparasol (or EmPro) embolic protection system, is intended for the treatment of carotid artery stenosis in patients with elevated risk for adverse events following carotid endarterectomy and meet the criteria outlined below:1. Patients who have either de novo atherosclerotic or post endarterectomy restenotic lesion(s) in the internal carotid arteries or at the carotid bifurcation with ?50% stenosis if symptomatic or ?80% stenosis if asymptomatic (both defined by angiography),AND2. Patients having a vessel with reference diameters between 3.5 mm and 9.0 mm at the target lesion.
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 |