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Device | VALIANT THORACIC STENT GRAFT WITH 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 | S012 |
Date Received | 07/29/2013 |
Decision Date | 01/22/2014 |
Product Code |
MIH |
Docket Number | 14M-167 |
Notice Date | 02/04/2014 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00413231
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM (VALIANT CAPTIVIA). THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF ALL LESIONS OF THE DESCENDING THORACIC AORTA (DTA) IN PATIENTS HAVING THE APPROPRIATE ANATOMY INCLUDING: 1) 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 MM TO 42 MM (FUSIFORM AND SACCULAR ANEURYSMS/PENETRATING ULCERS), OR 18 MM TO 44 MM (BLUNT TRAUMATIC AORTIC INJURIES), OR 20 MM TO 44 MM (DISSECTIONS); AND NONANEURYSMAL AORTIC PROXIMAL AND DISTAL NECK LENGTHS ¿ 20 (FUSIFORM AND SACCULAR ANEURYSMS/ PENETRATING ULCERS), LANDING ZONE ¿20 MM PROXIMAL TO THE PRIMARY ENTRY TEAR (BLUNT TRAUMATIC AORTIC INJURIES, DISSECTIONS). THE PROXIMAL EXTENT OF THE LANDING ZONE MUST NOT BE DISSECTED. |
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 |