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FDA Summary of Safety and Effectiveness

  • Device Generic Name:
    Total Artificial Heart

  • Device Trade Name:
    CardioWest temporary Total Artificial Heart
    The SynCardia temporary Total Artificial Heart was formerly known as the SynCardia temporary CardioWest™ Total Artificial Heart.

  • Applicant’s Name and Address:
    SynCardia Systems, Inc.
    1992 E. Silverlake Road
    Tucson, Arizona 85713

  • PMA Application Number:
    P030011

  • Date of Panel Recommendation:
    March 17, 2004

  • Date of Notice of Approval to the Applicant:
    October 15, 2004

Download the Document: "FDA Summary of Safety and Effectiveness"

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