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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
3033 campus drive
plymouth, MN 55441
PMA NumberP060001
Date Received01/09/2006
Decision Date01/24/2007
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 07M-0049
Notice Date 02/09/2007
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the protege gps and protege rx carotid stent systems. This device is indicated for used in conjunction with ev3 embolic protection devices, are indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet the following criteria:1) patients with carotid artery stenosis (>= 50% for symptomatic patients by ultrasound or angiography or >= 80% for asymptomatic patients by ultrasound or angiography) of the common or internal carotid artery, and2) patients must have a reference vessel diameter within the range of 4. 5 mm and 9. 5 mm at the target lesion.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S016 S017 S018 S019 
S020 S021 S022 S023 S024