BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P140012 · Supplement: S002 · Decision Dec 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT
    PMA Number
    P140012
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    LTI
    Generic Name
    IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
    Medical Specialty
    Unknown
    Advisory Committee
    Gastroenterology, Urology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 2015
    Date Received
    September 28, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) A NEW DELIVERY CATHETER GEN1; 2) PRODUCT PACKAGING FOR THE RESHAPE INTEGRATED DUAL BALLOON SYSTEM; 3) EXTENSION OF THE BALLOON AND DELIVERY CATHETER ASSEMBLY TO 24 MONTHS; AND 4) A NEW SUPPLIER FOR THE DELIVERY CATHETER ASSEMBLY (MEDBIO, INC., IN GRAND RAPIDS, MICHIGAN).

    Classifications

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

    Product Code Device Name
    LTI Implant, Intragastric For Morbid Obesity