BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Surmodics4211 (PT,SDB) - SurVeil Drug-Coated Balloon

    Reg #: 2030598 · FEI: 1000518731 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    2030598
    FEI Number
    1000518731
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9020 Activity Rd Ste D
    City
    SAN DIEGO
    State
    CA
    ZIP
    92126
    Country
    US

    Regulatory Submissions

    PMA Number
    P210025

    Owner / Operator

    Firm Name
    Synergy Health AST, LLC
    Operator Number
    10028672
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Drug-Eluting Peripheral Transluminal Angioplasty Catheter ONU

    Proprietary Names

    Surmodics4211 (PT,SDB) - SurVeil Drug-Coated Balloon

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)