Device Recall PROSTIVA RF Model 8929 Hand Piece

  • Modelo / Serial
    All lot numbers are included.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, RI, SC, SD, IN, TX, UT, VA, VT, WA, WI, WY, and WV and countries of Australia, New Zealand, China, Austria, Denmark, Finland, France, Germany, Italy, Kuwait, Lebanon, Norway, Qatar, Russian Federation, Spain, Sweden, Switzerland, and United Kingdom.
  • Descripción del producto
    PROSTIVA RF Model 8929 Hand Piece is the delivery system component of the PROSTIVA RF Therapy System. || PROSTIVA RF Therapy Kit 8929, Sterilized using ethylene oxide, Manufacturer Medtronic Inc Minneapolis, MN 55432-5604, Manufactured at Medtronic, Inc Villalba, Puerto Rico. || Indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 cm3 and 50 cm3.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA