Evidence strength in FDA premarket approval of cardiovascular devices.
Kong
David F
DF
Hasselblad
Vic
V
Krucoff
Mitchell W
MW
D002318:Cardiovascular Diseases / Q000628:therapy; D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000009:adverse effects / Q000145:classification; D016032:Randomized Controlled Trials as Topic; D012306:Risk; D035501:Uncertainty; D014481:United States; D014486:United States Food and Drug Administration