BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    BSCI (CR2) -POLARx FIT Cryoablation Balloon Catheter [Short Tip (ST)] POLARx FIT Cryoablation Balloon Catheter [Long Tip

    Reg #: 3010273872 · FEI: 3010273872 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Health AST, SRL
    Registration Number
    3010273872
    FEI Number
    3010273872
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    B13.1 Street 4, Avenue 1, Coyol Free Zone
    City
    Alajuela
    Country
    CR

    Regulatory Submissions

    PMA Number
    P220032

    Owner / Operator

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

    US Agent

    Business Name
    Synergy Health AST, LLC
    Contact Name
    Becky Aldhizer
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US
    Email
    [email protected]
    Phone
    440 3927490

    Products

    Device Name Product Code
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation OAE

    Proprietary Names

    BSCI (CR2) -POLARx FIT Cryoablation Balloon Catheter [Short Tip (ST)] POLARx FIT Cryoablation Balloon Catheter [Long Tip BSCI (CR2) - SMARTFREEZE Catheter Extension Cable SMARTFREEZE Cryo-Cable BSCI (CR2) - POLARx Cryoablation Balloon Catheter [Short Tip (ST)] POLARx Cryoablation Balloon Catheter [Long Tip (LT)]

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)