Published Online
on December 29, 2004

A more recent version of this article appeared on February 1, 2005

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Submitted on November 24, 2004
Accepted on November 29, 2004

The Food and Drug Administration Medical Device Review Process. Clearance of a Clot Retriever for Use in Ischemic Stroke

Richard P. Felten MS; Neil R.P. Ogden MS; Carlos Peña PhD; Miriam C. Provost PhD; Michael J. Schlosser MD; and Celia M. Witten PhD, MD^*

From the Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md.

^* To whom correspondence should be addressed. E-mail: cmw{at}cdrh.fda.gov.

Key words: acute care • stroke, ischemic

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