BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P110038 · Decision Sep 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
    PMA Number
    P110038
    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
    September 21, 2012
    Date Received
    November 4, 2011
    Expedited Review
    N
    Docket Number
    12M-1012

    Advisory Committee Statement

    APPROVAL FOR THE RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR REPAIR OF FUSIFORM ANEURYSMS AND SACCULAR ANEURYSMS/ PENETRATING ATHEROSCLEROTIC ULCERS IN THE DESCENDING THORACIC AORTA IN PATIENTS HAVING APPROPRIATE ANATOMY, INCLUDING: 1) ILIAC OR FEMORAL ACCESS VESSEL MORPHOLOGY THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, DEVICES AND/OR ACCESSORIES; 2) NON-ANEURYSMAL AORTIC NECK DIAMETER IN THE RANGE OF 19 - 42 MM; AND 3) NON-ANEURYSMAL PROXIMAL AORTIC NECK LENGTHS BETWEEN 15 AND 25 NUN AND DISTAL AORTIC NECK LENGTHS BETWEEN 25 AND 30 MM DEPENDING ON THE DIAMETER STENT-GRAFT REQUIRED.

    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