U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2008-D-0180
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, 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

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2008-D-0180.