Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™

  • 모델명 / 제조번호(시리얼번호)
    CD1233-40 Fortify™ VR CD2233-40Q Fortify™ DR CD3251-40 Unify Quadra™ CD3361-40C Unify Assura™ CD1233-40Q CD2235-40 Fortify™ ST DR CD3251-40Q CD3361-40Q CD1235-40 Fortify™ ST VR CD2235-40Q CD3255-40 Unify Quadra MP™ CD3361- 40QC CD1235-40Q CD2259-40 Fortify Assura™ DR CD3255-40Q CD3367-40 Quadra Assura™ CD1259-40 Fortify Assura™ VR CD2259-40Q CD3261-40 Unify Assura™ CD3367-40C CD1259-40Q CD2299-40 HeartMinder™ ST DR CD3261-40Q CD3367-40Q CD1299-40 HeartMinder™ ST VR CD2299-40Q CD3267-40 Quadra Assura™ CD3367- 40QC CD1299-40Q CD2359-40 Fortify Assura™ DR CD3267-40Q CD3371-40 Quadra Assura MP™ CD1359-40 Fortify Assura™ VR CD2359-40C CD3271-40 Quadra Assura MP™ CD3371-40C CD1359-40C CD2359-40Q CD3271-40Q CD3371-40Q CD1359-40Q CD2359- 40QC CD3281-40 Excelis Quadra™ CD3371- 40QC CD1359-40QC CD2391-40C HeartMinder™ + DR CD3281-40Q CD3385-40C Quadra + Excelis™ CD1391-40C HeartMinder™ + VR CD2391- 40QC CD3297-40 Excelis™ CRT-D CD3385- 40QC CD1391-40QC CD3235-40 Unify™ CD3297-40Q CD3389-40C Excelis™ + CD2233-40 Fortify™ DR CD3235-40Q CD3361-40 Unify Assura™ CD3389- 40QC
  • 의료기기 분류등급
  • Manufacturer
  • 1 Event

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    AMPMDRS

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial Number: všechny vyrobené do 23.5.2015
  • 의료기기 분류등급
  • 제품 설명
    Active implantable medical devices
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 제품 설명
    Implantable Cardioverter Defibrillator: St. Jude Medical Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™. Priority 1 – For Immediate Action
  • Manufacturer