BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P100040 · Supplement: S012 · Decision Jan 22, 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 WITH CAPTIVIA DELIVERY SYSTEM
    PMA Number
    P100040
    Supplement Number
    S012
    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 22, 2014
    Date Received
    July 29, 2013
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    14M-167

    Advisory Committee 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.

    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