www.fdanews.com/articles/145679-syncardia-nets-hud-designation-for-artificial-heart
SynCardia Nets HUD Designation for Artificial Heart
April 17, 2012
The FDA has approved a humanitarian use device (HUD) designation for SynCardia Systems’ temporary Total Artificial Heart to be used for destination therapy in addition to its current premarket approval as a bridge to transplant.
Cardiovascular Business
Cardiovascular Business