BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Program Module

    PMA: P880065 · Supplement: S006 · Decision Jul 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Pulse-Generator, Program Module
    Trade Name
    BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER
    PMA Number
    P880065
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    LOT
    Generic Name
    PULSE-GENERATOR, PROGRAM MODULE
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 30, 2001
    Date Received
    July 12, 2001
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MODIFICATION TO THE WARNING STATEMENT IN THE DIRECTIONS FOR USE MANUAL TO EXPAND ON THE POTENTIAL AFFECT OF RE-PROCESSING OR RE-STERILIZATION.

    Classifications

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

    Product Code Device Name
    LOT Pulse-Generator, Program Module