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GUIDANCE DOCUMENT

Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document April 2008

Draft

Not for implementation. Contains non-binding recommendations.

Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Devices and Radiological Health

This guidance is intended to be used as a companion document to the guidance Coronary Drug Eluting Stents — Nonclinical and Clinical Studies, which provides recommendations to sponsors or applicants planning to develop, or to submit to FDA, a marketing application for a coronary drug eluting stent (DES). This companion document provides additional and more detailed guidance on some of the recommendations in the Coronary Drug Eluting Stents guidance, including details on premarket approvals (PMAs), investigational device exemptions (IDEs), examples of various tables that may be submitted, and information on labeling a DES.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.