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Device | VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P100040 |
Supplement Number | S008 |
Date Received | 04/30/2012 |
Decision Date | 10/26/2012 |
Product Code |
MIH |
Docket Number | 12M-1109 |
Notice Date | 11/08/2012 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00413231
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Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF ISOLATED LESIONS (EXCLUDING DISSECTIONS) OF THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: ILIAC OR FEMORAL ARTERY ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES, OR ACCESSORIES; NONANEURYSMAL AORTIC DIAMETER IN THE RANGE OF 18 TO 42 MM (FUSIFORM AND SACCULAR ANEURYSMS/ PENETRATING ULCERS) OR 18 MM TO 44 MM (BLUNT TRAUMATIC AORTIC INJURIES); AND NONANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS >= 20 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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