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Based on limited metadata, this FDA Warning Letter issued to SynCardia Systems LLC on April 3, 2018, concerns a non-traditional medical device product. Without access to the full letter text or specific subject line, the precise nature of the violations cannot be determined from the available information. SynCardia Systems, known for artificial heart technology, appears to have been subject to FDA regulatory action, though the specific regulatory concerns and issuing office details are not documented in this metadata summary.