Cook, Inc.

2 dispositifs dans la base de données

  • Modèle / numéro de série
    REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
  • Description du dispositif
    Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile || Product Usage: || The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.
  • Modèle / numéro de série
    REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia
  • Description du dispositif
    Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile || Product Usage: || The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to:  Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD .  improve blood flow to the extremity.

4 fabricants avec un nom similaire

En savoir plus sur les données ici

  • Adresse du fabricant
    Cook, Inc., 750 Daniels Way, P.O. Box 489, Bloomington IN 47402-0489
  • Source
    USFDA
  • Adresse du fabricant
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA
  • Commentaire du fabricant
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHM