BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ascenda Catheter

    Reg #: 3004209178 · FEI: 3004369318 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Registration Number
    3004209178
    FEI Number
    3004369318
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ROAD 31, KM. 24, HM 4, CEIBA NORTE INDUSTRIAL PARK
    City
    Juncos
    State
    PR
    ZIP
    00777
    Country
    US

    Regulatory Submissions

    PMA Number
    P860004

    Owner / Operator

    Firm Name
    Medtronic, Inc.
    Operator Number
    2112641
    Address
    710 Medtronic Parkway
    City
    Minneapolis
    State
    MN
    Postal Code
    55432
    Country
    US

    Products

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

    Proprietary Names

    Ascenda Catheter Indura 1P Catheter N'Vision Software Application Card SynchroMed II Infusion Pump System N'Vision Programmer SynchroMed Infusion Pump System myPTM Personal Therapy Manager SynchroMed® II Clinician Programmer SynchroMed™ III PumpSynchroMed™ Clinician Programmer

    Establishment Types

    Manufacture Medical Device