BEUDAMED
    FDA Registration Active 🇫🇷 France

    Paradym RF CRT-D 9750

    Reg #: 3008159616 · FEI: 3008159616 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    Sorin CRM SAS
    Registration Number
    3008159616
    FEI Number
    3008159616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4, avenue Reaumur
    City
    CLAMART Hauts-de-Seine
    Country
    FR

    Regulatory Submissions

    PMA Number
    P060027

    Owner / Operator

    Firm Name
    MicroPort CRM USA, Inc.
    Operator Number
    2182863
    Address
    5677 Airline Road, Regulatory Affairs, c/o Dwyndl Nelms
    City
    Arlington
    State
    TN
    Postal Code
    38002
    Country
    US
    Correspondent
    John - Skousen

    US Agent

    Business Name
    MICROPORT CRM USA, INC.
    Contact Name
    John Skousen
    Address
    5677 Airline Road, Regulatory Affairs, c/o John Skuosen (MicroPort CRM)
    City
    Arlington
    State
    TN
    ZIP
    38002
    Country
    US
    Email
    [email protected]
    Phone
    801 3864437

    Products

    Device Name Product Code
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) NIK
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pacemaker/Icd/Crt Non-Implanted Components OSR
    Implantable Pacemaker Pulse-Generator DXY

    Proprietary Names

    Paradym RF CRT-D 9750 SMARTVIEW Home Monitor SMARTVIEW Hotspot Brady Remote Monitoring System PLATINIUM CRT-D 1741 PLATINIUM CRT-D 1711 Intensia CRT-D 174 ORCHESTRA Plus Link PLATINIUM 4LV CRT-D 1744 Paradym CRT-D 8750 Smart Monitor (Home monitor)

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility