title: Evidence strength in FDA premarket approval of cardiovascular devices.
authors.forename: David F
authors.initials: DF
authors.lastname: Kong
authors.forename: Vic
authors.initials: V
authors.lastname: Hasselblad
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: 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