HeartMate 12 volt sealed lead acid Battery Clips

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers are visible on the clips: 458560206, 581080207, 581080507, 34331720107, 34404690108, 34532990109, 343317201407, 34331720207,34331720507, 34404690208, 34404690308, 34404690408, 34432810108, 34450070108, 34477720108, 34570570109, 34577730109, 34331720307.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide - USA- AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and the District Columbia. Internationally to Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Lithuania, Luxembourg, Monaco, Netherlands, Singapore, South Africa, Sweden, Switzerland, Taiwan and the UK.
  • 제품 설명
    HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. || The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Thoratec Corp, 6035 Stoneridge Drive, Pleasanton CA 94588
  • Source
    USFDA