BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100040 · Supplement: S013 · Decision Jan 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM
    PMA Number
    P100040
    Supplement Number
    S013
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 7, 2014
    Date Received
    November 4, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee 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.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MIH System, Endovascular Graft, Aortic Aneurysm Treatment