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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/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.
 
DeviceCORDIS PRECISE NITINOL STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantCordis US Corporation
14201 N.W. 60th Avenue
Miami Lakes, FL 33014
PMA NumberP030047
Date Received10/08/2003
Decision Date09/22/2006
Product Code NIM 
Docket Number 06M-0412
Notice Date 10/17/2006
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S010 S014 S003 S004 S005 S007 S008 S017 S018 S013 S002 S011 
S012 S015 S021 S022 S019 S020 S035 S040 S033 S016 S032 S001 
S023 S024 S025 S027 S028 S029 S030 S031  S045 S009 S047 
S048 S049 S034 S036 S039 S038 S041 S042 S046 S044 S043 S050 
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