RT Journal
A1 De Alba F
T1 PErcutaneous heart valve
JF JAMA
JO JAMA
YR 2010
FD March 24
VO 303
IS 12
SP 1139
OP 1139
DO 10.1001/jama.2010.302
UL http://dx.doi.org/10.1001/jama.2010.302
AB 
The Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System was approved under the FDA's Humanitarian Device Exemption program, which allows the agency to approve a device for limited use in patients with conditions that affect fewer than 4000 US individuals each year. Products approved under the program can be used only at medical institutions that have an institutional review board to provide oversight.