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:
- 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"