BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Greatbatch Medical

    Reg #: 2183787 · FEI: 2183787 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    2
    Establishment Types
    4
    Classifications
    11

    Registration Details

    Registration Name
    Greatbatch Medical
    Registration Number
    2183787
    FEI Number
    2183787
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2300 Berkshire Lane North
    City
    Minneapolis
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130559
    PMA Number
    P130012

    Owner / Operator

    Firm Name
    GREATBATCH MEDICAL
    Operator Number
    9035261
    Address
    2300 Berkshire Lane N, --
    City
    Plymouth
    State
    MN
    Postal Code
    55441
    Country
    US

    Products

    Device Name Product Code
    Introducer, Catheter DYB
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Stimulator, Hypoglossal Nerve, Implanted, Apnea MNQ
    Stimulator, Spinal-Cord, Implanted (Pain Relief) GZB
    Instruments, Surgical, Cardiovascular DWS
    Pacemaker Lead Adaptor DTD
    Permanent Defibrillator Electrodes NVY
    Permanent Pacemaker Electrode DTB
    Catheter, Intracardiac Mapping, High-Density Array MTD
    Catheter, Percutaneous DQY

    Proprietary Names

    Vein Pick Fixation Tool

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198