TY  - JOUR
T1  - PErcutaneous heart valve
AU  - De Alba F
Y1  - 2010/03/24
N1  - 10.1001/jama.2010.302
JO  - JAMA
SP  - 1139
EP  - 1139
VL  - 303
IS  - 12
N2  - 
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.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2010.302
UR  - http://dx.doi.org/10.1001/jama.2010.302
ER  -