title: A pivotal medical-device case.
authors.forename: Gregory D
authors.initials: GD
authors.lastname: Curfman
authors.forename: Stephen
authors.initials: S
authors.lastname: Morrissey
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Drazen
mesh_terms: D006328:Cardiac Catheterization / Q000295:instrumentation; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence; D016365:Liability, Legal; D010138:Pacemaker, Artificial; D028701:Patient Rights / Q000331:legislation & jurisprudence; D013219:State Government; D035521:Supreme Court Decisions; D014481:United States; D014486:United States Food and Drug Administration