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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.
 
Trade NameCORDIS PRECISE NITINOL STENT SYSTEM
Classification Namestent, carotid
ApplicantCORDIS CORP.
PMA NumberP030047
Date Received10/08/2003
Decision Date09/22/2006
Product Code
NIM[ Registered Establishments with NIM ]
Docket Number 06M-0412
Notice Date 10/17/2006
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the cordis precise nitinol stent system (5. 5 fr and 6. 0 fr sizes, over-the-wire configuration). This device is indicated for use in conjunction with the angioguard xp emboli capture guidewire for the treatment of patients at high risk for adverse events from carotid endarterectomy (defined in the ifu) who require carotid revascularization and meet the criteria outlined below: 1) patients with neurological symptoms and >=50% stenosis of the common or internal carotid artery by ultrasound or angiogram or patients without neurological symptoms and >=80% stenosis of the common or internal carotid artery by ultrasound or angiogram, and 2) patients must have a vessel diameter of 4-9mm at the target lesion. The vessel distal to the target lesion must be within the range of 3mm and 7. 5mm to allow for placement of the angioguard xp emboli capture guidewire.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 
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