BEUDAMED
    FDA Registration Active 🇫🇷 France

    Paradym DR 8550

    Reg #: 3008159616 · FEI: 3008159616 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    17
    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
    P980049

    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
    Implantable Pacemaker Pulse-Generator DXY
    Defibrillator, Implantable, Dual-Chamber MRM
    Implantable Cardioverter Defibrillator (Non-Crt) LWS
    Pacemaker/Icd/Crt Non-Implanted Components OSR

    Proprietary Names

    Paradym DR 8550 Intensia VR 124 Paradym RF DR 9550 Paradym RF VR 9250 Paradym VR 8250 SMARTVIEW Home Monitor PLATINIUM DR 1510 Intensia DR 154 PLATINIUM VR 1240 PLATINIUM DR 1540 PLATINIUM VR 1210 Accessory for pacemaker, ICD and CRT-D Screw driver Orchestra Plus Programmer Smart Monitor CPR4 SmartTouch Programmer Software (SmartView) Remote Monitoring Software

    Establishment Types

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