BEUDAMED
    FDA Registration Active 🇨🇷 Costa Rica

    ALLERGAN

    Reg #: 9617229 · FEI: 3006108784 · Expires 2026
    View on FDA
    Products
    9
    Proprietary Names
    35
    Establishment Types
    3
    Classifications
    9

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    Registration Details

    Registration Name
    ALLERGAN
    Registration Number
    9617229
    FEI Number
    3006108784
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    900 PARKWAY GLOBAL PARK
    City
    LA AURORA DE HEREDIA
    Country
    CR

    Regulatory Submissions

    510(k) Number
    K862203
    PMA Number
    P040046

    Owner / Operator

    Firm Name
    AbbVie, Inc.
    Operator Number
    2011068
    Address
    2525 DUPONT DRIVE, --
    City
    Irvine
    State
    CA
    Postal Code
    92612
    Country
    US
    Correspondent
    James P Wabby

    US Agent

    Business Name
    ABBVIE, INC.
    Contact Name
    James Wabby
    Address
    2525 Dupont Dr
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2462259

    Products

    Device Name Product Code
    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled FTR
    Tissue Expander And Accessories LCJ
    Prosthesis, Breast, Inflatable, Internal, Saline FWM
    Mammary Sizer MRD
    Kit, Surgical Instrument, Disposable KDD
    Set, Administration, Intravascular FPA
    Template HWT
    Dermal Cooling Pack/Vacuum/Massager OOK
    Brush, Dermabrasion, Powered GFE

    Proprietary Names

    Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants: FF,FM,FL,MF,MM, ML,LF,LM,LL,FX,MX,LX Natrelle 133 Tissue Expander Natrelle 133 Tissue Expander No Suture Tabs: 133 FV, 133 FX, 133 MV, 133 MX, 133 SX, 133 SV, 133 LV Natrelle 133 Plus Tissue Expander Natrelle 133 Plus Tissue Expander - 133P FV, 133P FX, 133P MV, 133P MX, 133P SX, 133P SV, 133P LV CUI Versafil Tissue Expanders Natrelle Saline-Filled Breast Implants: 10, 15, 20, 40, 45, 110, 115, 120 Natrelle Inspira Breast Implants: SRL, SRLP, SRM, SRF, SRX, TRF, TRL, TRLP, TRM, TRX, SSF, SSM, SSL, SSLP, SSX Natrelle Inspira Cohesive Breast Implants: SCF, SCL, SCLP, SCM, SCX, TCF, TCL, TCLP, TCM, TCX Natrelle Saline-Filled Breast Implants Natrelle Saline-Filled Breast Implants - 68MP, 68HP, 68LP, 363LF, 163, 168, 468 Natrelle 133 Tissue Expander - Suture Tabs: 133 FV-T, 133 FX-T, 133 MV-T, 133 MX-T, 133 SV-T, 133 SX-T, 133 LV-T Natrelle 133 Tissue Expander with Suture Tabs NATRELLE INSPIRA Single Use Sizers for Gel Implants Insertion Sleeve; Keller Funnel; Keller Funnel 2 Fill Tube Kit Safsite Injection Site Reflux Valve Natrelle 133S Tissue Expander Styles: S-FV, S-FX, S-MV, S-MX, S-SX, S-SV Natrelle 133S Tissue Expander Styles: 133S FV-T, 133S FX-T, 133S MV-T, 133S MX-T, 133S SV-T, 133S SX-T, 133S LV-T MagnaFinder Xact Infusion Set, Universal Fill Kit, Winged Infusion Set Style 133 Series Templates Natrelle Inspira Re-ster Sizers: MSZ-F, MSZ-L, MSZ-LP, MSZ-M, MSZ-X, , MSZST-F, MSZST-L, MSZST-LP, MSZST-M, MSZST-X Natrelle410 Re-ster Sizers:MSZ-FL, MSZ-ML,MSZ-LL, MSZ-LM, MSZ-MX, MSZ-LF, MSZ-FX, MSZ-LX, MSZ-MM, MSZ-MF, MSZ-FM, MSZ-FF Natrelle Re-sterilizable Sizer: MSZ Natrelle Re-ster Sizers: MSZ-10, MSZ-15, MSZ-20, MSZ-45 CoolSculpting Elite System SilkPeel Spa EnDoucer Dermolissage SilkPeel Pro SilkPeel MD DPRO SP3 Silk Peel Dermalinfusion

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device