BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    CapSure Sense MRI SureScan Leads

    Reg #: 3008973940 · FEI: 3008973940 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    8
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Medtronic Singapore Operations Pte Ltd
    Registration Number
    3008973940
    FEI Number
    3008973940
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    49 Changi South Avenue 2, Nasaco Tech Centre
    City
    Singapore Central Singapore
    Country
    SG

    Regulatory Submissions

    PMA Number
    P830061

    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
    Permanent Pacemaker Electrode DTB
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes NVN
    Permanent Defibrillator Electrodes NVY

    Proprietary Names

    CapSure Sense MRI SureScan Leads Adhesive CapSure Unipolar Lead Vitatron Crystalline Lead Vitatron Excellence PS+ Lead stylet kit CapSure Sense Capsure SP Novus

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device