BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    System, Endovascular Graft, Aortic Aneurysm Treatment

    PMA: P070016 · Decision May 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    System, Endovascular Graft, Aortic Aneurysm Treatment
    Trade Name
    ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
    PMA Number
    P070016
    Device Class
    FDA Class 3
    Product Code
    MIH
    Generic Name
    SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    May 21, 2008
    Date Received
    July 2, 2007
    Expedited Review
    N
    Docket Number
    08M-0311

    Advisory Committee Statement

    APPROVAL FOR THE ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEMS; AND 2) NON-ANEURYSMAL AORTIC SEGMENTS (FIXATION SITES) PROXIMAL AND DISTAL TO THE ANEURYSM OR ULCER: A) WITH A LENGTH OF AT LEAST 25 MM; AND B) WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 38 MM AND NO LESS THAN 24 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