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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Namestent, carotid
Generic Namestent,carotid
PMA NumberP050019
Date Received05/24/2005
Decision Date10/23/2008
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 08M-0596
Notice Date 12/01/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018