Device Recall Cardiogenesis Transmyocardial the SoloGrip III (HP5G3) and the PEARL 5.0 (HPPRL5).

  • 모델명 / 제조번호(시리얼번호)
    Product Code - HP-SG3 Product Code -HP-PRL5
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    US Distribution
  • 제품 설명
    Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. || The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cardiogenesis Corporation, 1655 Roberts Blvd NW, Kennesaw GA 30144-3632
  • 제조사 모회사 (2017)
  • Source
    USFDA