BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S046 · Decision Jun 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED IMPLANTABLE INFUSION PUMP SYSTEM
    PMA Number
    P860004
    Supplement Number
    S046
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 29, 2001
    Date Received
    June 18, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THREE NEW PUMP CONNECTOR DESIGNS AND A CHANGE IN THE MODEL 8709 CATHETER KIT CONTENTS: 1) NEW MODEL 8575 400 PUMP CONNECTOR FOR THE MODEL 8709 INTRATHECAL CATHETER. 2) NEW MODEL 8577 900 PUMP CONNECTOR FOR THE MODEL 8709 INTRATHECAL CATHETER. 3) NEW MODEL 8576 900 PUMP CONNECTOR FOR USE WITH THE MODEL 8700A AND MODEL 8700V VASCULAR CATHETERS. 4) NEW MODEL 8709 CATHETER KITS WILL REPLACE THE CURRENT CATHETERS WITH THE 400 MODEL 8575 PUMP CONNECTOR FOR SYNCHROMED PUMPS WITH A CAP (CATHETER ACCESS PORT), OR A MODEL 8577 900 PUMP CONNECTOR FOR A SYNCHROMED PUMP WITHOUT A CAP.

    Classifications

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

    Product Code Device Name
    LKK Pump, Infusion, Implanted, Programmable