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Device | ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040012 |
Date Received | 03/15/2004 |
Decision Date | 08/30/2004 |
Product Code |
NIM |
Docket Number | 04M-0388 |
Notice Date | 09/03/2004 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM. THE ACCULINK CAROTID STENT SYSTEM AND THE RX ACCULINK CAROTID STENT SYSTEM, USED IN CONJUNCTION WITH GUIDANT CAROTID EMBOLIC PROTECTION SYSTEMS, ARE INDICATED FOR THE TREATMENT OF PATIENTS AT HIGH RISK FOR ADVERSE EVENTS FROM CAROTID ENDARTERECTOMY 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, AND2) PATIENTS MUST HAVE A REFERENCE VESSEL DIAMETER WITHIN THE RANGE OF 4.0 MM AND 9.0 MM AT THE TARGET LESION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S039 S040 S042 S054 S001 S045 S046 S047 S048 S043 S052 S003 S026 S030 S027 S016 S017 S018 S019 S020 S022 S023 S056 S059 S036 S037 S038 S041 S044 S049 S051 S055 S053 S050 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S024 S029 S028 S031 S033 S034 S035 S025 S032 S057 S058 S060 S062 S064 S061 S063 |