BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Shockwave7578 (PT,SDB*) - Shockwave C2 Coronary IVL Catheters

    Reg #: 3012102437 · FEI: 3012102437 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Synergy Health AST, LLC
    Registration Number
    3012102437
    FEI Number
    3012102437
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3200 Lakeville Hwy, Suite 120
    City
    Petaluma
    State
    CA
    ZIP
    94954
    Country
    US

    Regulatory Submissions

    PMA Number
    P200039

    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
    Shockwave Intravascular Lithotripsy System QMG

    Proprietary Names

    Shockwave7578 (PT,SDB*) - Shockwave C2 Coronary IVL Catheters Shockwave7578 (PT,SDB*) - Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)