HEARTMATE II LVAS - IMPLANT KIT

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 1355 (Lot serial: VAD-4087); Model Catalog: 1355 (Lot serial: VAD-0693); Model Catalog: 1355 (Lot serial: VAD-4113); Model Catalog: 1355 (Lot serial: VAD-1401)
  • 의료기기 분류등급
  • 제품 설명
    HeartMate II LVAS percutaneous lead
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    PLEASANTON
  • 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
    HC

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 1355 (Lot serial: < 50 devices); Model Catalog: 102139 (Lot serial: < 50 devices)
  • 의료기기 분류등급
  • 제품 설명
    HeartMate II Left Ventricular Assist Sy
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 106015 (Lot serial: Pocket Controller Model 105109); Model Catalog: 106015 (Lot serial: Contact Manufacturer); Model Catalog: 106015 (Lot serial: All serial numbers); Model Catalog: 106762 (Lot serial: Contact Manufacturer); Model Catalog: 106016 (Lot serial: All serial numbers); Model Catalog: 106762 (Lot serial: Pocket Controller Model 105109); Model Catalog: 106016 (Lot serial: Pocket Controller Model 105109); Model Catalog: 106762 (Lot serial: All serial numbers); Model Catalog: 106016 (Lot serial: Contact Manufacturer); Model Catalog: 106017 (Lot serial: Pocket Controller Model 105109); Model Catalog: 106017 (Lot serial: Contact Manufacturer); Model Catalog: 106017 (Lot serial: All serial numbers)
  • 의료기기 분류등급
  • 제품 설명
    HeartMate II LVAS Implant Kit with Sealed Grafts (NAm)
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 104911 (Lot serial: ALL LOTS); Model Catalog: 104692 (Lot serial: ALL LOTS); Model Catalog: 103393 (Lot serial: ALL LOTS)
  • 제품 설명
    HM II Implant Kit Sealed
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 103695 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 103696 (Lot serial: >100 NUMBERS CONTACT MFG)
  • 제품 설명
    THORATEC HEARTMATE II LEFT VENTRICULAR
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 107801 (Lot serial: ALL); Model Catalog: 106015 (Lot serial: ALL); Model Catalog: 106762 (Lot serial: ALL)
  • 의료기기 분류등급
  • 제품 설명
    HeartMate II LVAS Implant Kit
  • Manufacturer