BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    Paradym RF CRT-D Model 9750

    Reg #: 1000165971 · FEI: 1000165971 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    MicroPort CRM S.r.l.
    Registration Number
    1000165971
    FEI Number
    1000165971
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Crescentino s.n
    City
    Saluggia (VC) Vercelli
    Country
    IT

    Regulatory Submissions

    PMA Number
    P060027

    Owner / Operator

    Firm Name
    MicroPort CRM S.R.L.
    Operator Number
    9059364
    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
    Contact Name
    John Skousen
    Address
    5677 AIRLINE ROAD, REGULATORY AFFAIRS, C/O DWYNDL NELMS
    City
    Arlington
    State
    TN
    ZIP
    38002
    Country
    US
    Email
    [email protected]
    Phone
    801 3864437

    Products

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

    Proprietary Names

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

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device