Device Recall Permanent Pacing Lead

  • 모델명 / 제조번호(시리얼번호)
    02-01502, 02-01812, 02-01436, 02-01440, 02-02016, and 02-01945
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU, BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Manufactured by Oscor. || Pacing and sensing of the ventricle and/or atrium of the heart in conjunction with a compatible, implantable pulse generator/pacemaker.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Oscor, Inc., 3816 De Soto Blvd., Palm Harbor FL 34683-1618
  • 제조사 모회사 (2017)
  • Source
    USFDA