Amplatzer PFO Occluder

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    SATP

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot number M06B01-52, serial numbers 190477 - 190494
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
  • Product Description
    AMPLATZER PFO Occluder. Order No. 9-PFO-018. Device is not PMA approved in the US. 18mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
  • Manufacturer
  • Model / Serial
    Lot number M06B01-58, serial numbers 190495 - 190512
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Foreign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
  • Product Description
    AMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
  • Manufacturer
  • Model / Serial
    Model Catalog: 9-PFO-025 (Lot serial: M08AXX); Model Catalog: 9-PFO-018 (Lot serial: LOT NUMBERS BEGINNING WITH); Model Catalog: 9-PFO-030 (Lot serial: LOT NUMBERS BEGINNING WITH); Model Catalog: 9-PFO-035 (Lot serial: LOT NUMBERS BEGINNING WITH); Model Catalog: 9-PFO-025 (Lot serial: M07LXX); Model Catalog: 9-PFO-018 (Lot serial: M07LXX); Model Catalog: 9-PFO-030 (Lot serial: M07LXX); Model Catalog: 9-PFO-035 (Lot serial: M07LXX); Model Catalog: 9-PFO-035 (Lot serial: M08AXX); Model Catalog: 9-PFO-030 (Lot serial: M08AXX); Model Catalog: 9-PFO-018 (Lot serial: M08AXX); Model Catalog: 9-PFO-025 (Lot serial: LOT NUMBERS BEGINNING WITH); Model Catalog: 9-PFO-035 (Lot serial: M07MXX); Model Catalog: 9-PFO-030 (Lot serial: M07MXX); Model Catalog: 9-PFO-018 (Lot serial: M07MXX); Model Catalog: 9-PFO-025 (Lot serial: M07MXX)
  • Product Description
    AMPLATZER PFO Occluder
  • Manufacturer