Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VALIANT THORACIC STENT GRAFT SYSTEM 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 | S013 |
Date Received | 11/04/2013 |
Decision Date | 01/07/2014 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A PRODUCT LINE EXTENSION CONSISTING OF THE ADDITION OF 11 VALIANT FREEFLO TAPERED STENT GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM AND 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. |
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