St. Jude Medical Cardiovascular Division

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Description

5 dispositifs dans la base de données

  • Modèle / numéro de série
    Batches: 3107789, 3107790
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
  • Description du dispositif
    St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .038" Max Guidewire O.D., Rx, Sterile EO, REF C408507,100017564.
  • Modèle / numéro de série
    Batches in US: 3103891, 3110889, 3110892, 3118794, 3123051.   Batches OUS: 3110892, 3118797
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
  • Description du dispositif
    St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408502, 100017543.
  • Modèle / numéro de série
    Batch in US and OUS: 3107645
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
  • Description du dispositif
    St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 25 cm length, .035" Max Guidewire O.D., Rx, Sterile EO, REF C408513, 100017549.
  • Modèle / numéro de série
    Batch: 3105838
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
  • Description du dispositif
    St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 12 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408527, 100028094.
  • Modèle / numéro de série
    Batch: 3109782
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA, Italy, Denmark, France, Switzerland, England, Finland, Austria, Spain and Estonia.
  • Description du dispositif
    St. Jude Medical, Engage TR Introducer, 6 F - ACT (2.25 mm), 7 cm length, .025" Max Guidewire O.D., Rx, Sterile EO, REF C408524, 100028093.

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En savoir plus sur les données ici

  • Adresse du fabricant
    St. Jude Medical Cardiovascular Division, 14901 Deveau Pl, Minnetonka MN 55345-2126
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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
    USFDA