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Device | CORDIS PRECISE NITINOL STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | Cordis US Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
PMA Number | P030047 |
Date Received | 10/08/2003 |
Decision Date | 09/22/2006 |
Product Code |
NIM |
Docket Number | 06M-0412 |
Notice Date | 10/17/2006 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | Yes |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Recalls | CDRH 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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show 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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