title: The Food and Drug Administration medical device review process: clearance of a clot retriever for use in ischemic stroke.
authors.affiliation: Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md 20815, USA.
authors.forename: Richard P
authors.initials: RP
authors.lastname: Felten
authors.forename: Neil R P
authors.initials: NR
authors.lastname: Ogden
authors.forename: Carlos
authors.initials: C
authors.lastname: Peña
authors.forename: Miriam C
authors.initials: MC
authors.lastname: Provost
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Schlosser
authors.forename: Celia M
authors.initials: CM
authors.lastname: Witten
mesh_terms: D002545:Brain Ischemia / Q000601:surgery* / Q000628:therapy; D002404:Catheterization / Q000295:instrumentation / Q000592:standards; D002986:Clinical Trials as Topic; D018795:Device Approval; D017128:Embolectomy / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D004869:Equipment Safety; D006801:Humans; D020766:Intracranial Embolism / Q000601:surgery*; D020521:Stroke / Q000601:surgery* / Q000628:therapy; D014481:United States; D014486:United States Food and Drug Administration