| 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. |
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| Device | Roadsaver/CASPER Carotid Stent Device |
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| Generic Name | Stent, carotid |
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| Applicant | MicroVention, Inc.
1311 Valencia Ave.
Tistin, CA 92780 |
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| PMA Number | P210030 |
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| Date Received | 07/28/2021 |
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| Decision Date | 11/20/2024 |
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| Product Code |
NIM |
| Advisory Committee |
Cardiovascular |
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| Clinical Trials | NCT02657707
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 |
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