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CLOSEOUT LETTER

SynCardia Systems LLC MARCS-CMS 537226 — Jun 11, 2019

SynCardia Systems LLC - 537226 - 06/11/2019

Delivery Method:
United Parcel Service
Product:
Medical Devices

Recipient:
Recipient Name
Don Webber
Recipient Title
Chief Operating Officer
SynCardia Systems LLC

1992 East Silverlake Road
Tucson, AZ 85713
United States

Issuing Office:
Center for Devices and Radiological Health

19701 Fairchild Road
Los Angeles, CA 92612
United States


Dear Mr. Webber,

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter (WL #537226), dated 04/03/2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Bryan Love
Acting Compliance Branch Director
Division 3/West
Office of Medical Device and Radiological Health Operations