Quadra Assura MP

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    U.S. Nationwide distribution
  • Description du dispositif
    Quadra Assura MP, Sterile EO, Model #/ Part #: || CD3269-40/100043177; || CD3269-40Q/100043178; || CD3271-40/100043130; || CD3271-40Q/100043191; || CD3369-40C/100080339, 100080478; || CD3369-40Q/100080439, 100080476, 100105528; || CD3371-40/100078814, 100079232, 100079513; || CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; || CD3371-40Q/100078815,100079282, 100079479, 100138237; || CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; || CD3387-40C/100105525; || CD3387-40QC/100138158
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    St Jude Medical Inc., 15900 Valley View Ct, Sylmar CA 91342-3577
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA

25 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Models: CD1233-40, CD1233-40Q, CD1235-40, CD1235-40Q, CD1259-40, CD1259-40Q, CD1299-40 .. (See APPENDIX for details) FDA Update Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q
  • Classification du dispositif
  • Description du dispositif
    Implantable Cardioverter Defibrillator
  • Manufacturer
  • Modèle / numéro de série
  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Active implantable medical devices - defibrillators
  • Manufacturer
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