Devices

Device Recall AMPLATZER PFO Occluder

  • Model / Serial
    Lot number M06B01-52, serial numbers 190477 - 190494
  • Product Classification
    Cardiovascular Devices
  • 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
    AGA Medical Corporation
  • 1 Event

Manufacturer

AGA Medical Corporation
  • Manufacturer Address
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA

One device with a similar name

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Device Recall AMPLATZER PFO Occluder
  • Model / Serial
    Lot number M06B01-58, serial numbers 190495 - 190512
  • Product Classification
    Cardiovascular Devices
  • 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
    AGA Medical Corporation