Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003761017

FEI Number

3003761017

Entity Name

SYNCARDIA SYSTEMS, LLC

City/State/Country

TUCSON, AZ, US

Establishment Address

1992 E Silverlake Rd, TUCSON, AZ 85713, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SYNCARDIA SYSTEMS, LLC (Owner Number: 9067898)

Owner / Operator Contact Address

1992 E. SILVERLAKE RD., Tucson, AZ 85713, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P030011

All Registered Proprietary Names

SynCardia Systems, LLC Total Artificial Heart

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOZ	Artificial Heart	Unknown	Class 3	N/A	2007-11-26

Official Correspondent

Michael Larsen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SYNCARDIA SYSTEMS, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003761017. Last updated year: 2026. Please use registration number 3003761017 when referencing this establishment in official correspondence.