PMDA Approves Jarvik 2000 Heart in Japan
The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval to the Shonin (or pre-market approval) application submitted by Century Medical, Inc., (CMI) for the Jarvik 2000 Heart.
Full FDA Approval of the Jarvik 2000® Destination Therapy Trial
Device to provide long-term, permanent support for heart failure patients who are not eligible for transplant. Approval was also granted for Continuing Access Protocol (CAP) patients following completion of enrollment in the bridge to transplant trial.