BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JENAVALVE TECHNOLOGY, INC.

    Reg #: 3012148004 · FEI: 3012148004 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    JENAVALVE TECHNOLOGY, INC.
    Registration Number
    3012148004
    FEI Number
    3012148004
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4 Cromwell
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    PMA Number
    P250024

    Owner / Operator

    Firm Name
    JenaValve Technology, Inc.
    Operator Number
    10051384
    Address
    4 Cromwell
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Tonya Porter

    Products

    Device Name Product Code
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT

    Proprietary Names

    Trilogy Loading Tools JenaValve Trilogy Transcatheter Heart Valve System Trilogy Introducer Sheath Trilogy Transcatheter Heart Valve (THV) Trilogy Delivery Catheter JenaValve

    Establishment Types

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