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Device | GORE TAG THORACIC ENDOPROSTHESIS |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W. L. GORE & ASSOCIATES, INC. 3450 KILTIE LANE P.O. BOX 2400 FLAGSTAFF, AZ 86003-2400 |
PMA Number | P040043 |
Date Received | 10/04/2004 |
Decision Date | 03/23/2005 |
Product Code |
MIH |
Docket Number | 05M-0320 |
Notice Date | 08/12/2005 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE TAG THORACIC ENDOPROSTHESIS AND DELIVERY CATHETER. THE DEVICE IS INTENDED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA IN PATIENTS WHO HAVE APPROPRIATE ANATOMY INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS. 2) AORTIC INNER DIAMETER IN THE RANGE OF 23-37 MM. 3) >=2 CM NON-ANEURYSMAL AORTA PROXIMAL AND DISTAL TO THE ANEURYSM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 S073 S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 S084 S085 S086 S087 S089 S090 S092 S093 S094 S095 S096 S097 S098 S099 S101 S102 S103 S104 S105 S106 S107 S108 S109 S110 S111 S113 S114 S115 S116 S117 S118 S119 S120 S121 S123 S124 S125 S126 S127 S128 S129 S130 S131 S132 S133 S134 S135 S136 S138 S139 |