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Device | VALIANT THORACIC STENT GRAFT SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100040 |
Date Received | 10/08/2010 |
Decision Date | 04/01/2011 |
Product Code |
MIH |
Docket Number | 11M-0257 |
Notice Date | 04/20/2011 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00413231
|
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FALIANT THORACIC STENT GRAFT WITH THE CAPTIVA DELIVERY SYSTEM. THE DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF FUSIFORM AND ANEURYSMS/PENETRATING ULCERS OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: 1) ILIAC/FEMORAL ACCESS VESSLE MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, AND/OR ACCESSORIES; 2) NON-ANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18-42 MM; AND 3) NON-ANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS >=20 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
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 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S041 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S067 |