The Precision Spinal Cord Stimulator System

  • 모델명 / 제조번호(시리얼번호)
    Model Number: SC-9305, Lot Number 170338
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution including Great Britian
  • 제품 설명
    OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 || The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with following: failed back surgery syndrome, intractable low back pain and leg pain. The Precision System includes an implantable l6-output, multi-channel stimulator (lPO - Implantable Pulse Generator) with a rechargeable battery power source. The lPG, commonly implanted in the abdomen or buttock area, can be configured to accept one or two leads. The leads are implanted in the epidural space, adjacent to the spinal column. The stimulation delivered at the distal end of the lead is intended to mask the pain signals.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Advanced Bionics Corporation, 12740 San Fernando Rd, Bldgs. 1 & 3, Sylmar CA 91342
  • Source
    USFDA