Medtronic MiniMed(TM) Silhouette(TM)

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 5179979 5182542 5185471 5187173 5188894 5189581 5191349 5192467 5178077 5189588 5181137 5181140 5184757 5184758 5186199 5186203 5188890 5191350 5193510 5186206 5179854 5179857 5179975 5181712 5182176 5182543 5183121 5185154 5185157 5186200 5186201 5186202 5187102 5187170 5188889 5188893 5190033 5190708 5190710 5191351 5192470 5192679 5194101 5168207 5189592 5175824 5176442 5179855 5179977 5181711 5181713 5182177 5182179 5182544 5183122 5183123 5184087 5185155 5185156 5187101 5187171 5187817 5188886 5188887 5188888 5188895 5189583 5189584 5189585 5189586 5190031 5190707 5190709 5192468 5192469 5192471 5192680 5192691 5192692 5193308 5194100 5178081 5185473 5186207 5187821 5189590 5191354 5178084 5183072 5185153 5187103 5187818 5187819 5187820 5188892 5193505 5178076 5189591 5175953 5181138 5185472 5187172 5191352 5192682 5186205 5181139 5186204 5189587
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide
  • 제품 설명
    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic Inc., 18000 Devonshire St, Northridge CA 91325-1219
  • 제조사 모회사 (2017)
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA