| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS |
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| Classification Name | stent, carotid |
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| Generic Name | stent,carotid |
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| Applicant | BOSTON SCIENTIFIC CORP. |
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| PMA Number | P050019 |
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| Date Received | 05/24/2005 |
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| Decision Date | 10/23/2008 |
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| Product Code | |
| Docket Number | 08M-0596 |
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| Notice Date | 12/01/2008 |
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| Advisory Committee |
Cardiovascular |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the carotid wallstent monorail endoprosthesis. The device, used in conjunction with the boston scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease and meet the criteria outlined below: 1) patients with neurological symptoms and > 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, or patients without neurological symptoms and > 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, and; 2) patients with a reference vessel diameter within the range of 4. 0 mm and 9. 0 mm at the target lesion. |
| Approval Order |
Approval Order
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| Post-Approval Study | Show Report Schedule and Study Progress |
| Supplements: |
S001 S002 S003 S004 S005 S006
S007 S008 S009 S010 S011 S012
S013 |
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