title: The extrapolation of study results in the device approval process.
authors.forename: John C
authors.initials: JC
authors.lastname: Somberg
mesh_terms: D001281:Atrial Fibrillation / Q000175:diagnosis / Q000601:surgery*; D017115:Catheter Ablation / Q000295:instrumentation* / Q000379:methods; D002404:Catheterization; D002986:Clinical Trials as Topic; D018795:Device Approval; D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration