BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implant, Intragastric For Morbid Obesity

    PMA: P000008 · Supplement: S002 · Decision Aug 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Implant, Intragastric For Morbid Obesity
    Trade Name
    BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
    PMA Number
    P000008
    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
    August 1, 2002
    Date Received
    January 24, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE LAP-BAND ADUSTABLE GASTRIC BANDING (LAGB) SYSTEM: 1) INTRODUCTION OF A REDESIGNED ACCESS PORT (ACCESS PORT II); 2) REPLACE THE CALIBRATION TUBE (CALIBRATION TUBE I) CURRENTLY PROVIDED IN THE LAGB) SYSTEM WITH A REDESIGNED CALIBRATION TUBE (CALIBRATION TUBE II); AND 3) INTRODUCTION OF 2" ACCESS PORT NEEDLES TO BE SOLD AS AN ACCESSORY ITEM. IN ADDITION TO BEING SOLD AS COMPONENTS OF THE LAGB SYSTEM, BOTH THE ACCESS PORT II AND THE CALIBRATION TUBE II WILL BE SOLD AS SEPARATE ACCESSORIES.

    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