Fortify Assura

  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    U.S. Nationwide distribution
  • Product Description
    Fortify Assura, Sterile EO, Model #/ Part #: || CD1257-40/100042322, 100059623; || CD1257-40Q/100042341, 100059535; || CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; || CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; || CD1263-40/100042948; || CD1263-40Q/100042949; || CD1357-40C/100080365, 100080377, 100083441; || CD1357-40Q/100080389, 100080390, 100083388; || CD1359-40/100078740, 100083267, 100096839; || CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; || CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; || CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; || CD1363-40C/100080349; || CD1363-40Q/100080317; || CD1391-40C/100080756; || CD1391-40QC/100080783; || CD2257-40/100042337, 100059839; || CD2257-40Q/100042342, 100059842; || CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; || CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; || CD2263-40/100042950; || CD2263-40Q/100043201; || CD2357-40C/100080404, 100080413, 100083490; || CD2357-40Q/100080319, 100080412, 100083492; || CD2359-40/100078750, 100083466; || CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; || CD2359-40Q/100078841, 100079109, 100083472; || CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; || CD2363-40C/100080416; || CD2363-40Q/100080407; || CD2391-40C/100080784; || CD2391-40QC/100080744
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    St Jude Medical Inc., 15900 Valley View Ct, Sylmar CA 91342-3577
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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

37 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    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 || Product Usage Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing
  • Manufacturer
  • Model / Serial
    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
  • Product Classification
  • Product Description
    Implantable Cardioverter Defibrillator
  • Manufacturer
32 more