FDA 裸支架评价指南.pdf

Guidance for Industry and FDA Staff Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems Document issued on: January 13, 2005 For questions regarding this document contact Vivianne Holt at 240-276-4141 or by e-mail at vivianne.holt@. U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Interventional Cardiology Devices Branch Peripheral Vascular Devices Branch Division of Cardiovascular Devices Office of Device Evaluation Contains Nonbinding Recommendations Preface Public Comment Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated. Additional Copies Additional copies are available from the Internet at /cdrh/ode/guidance/1545.pdf or you may either send a fax request to (301) 443-8818 to receive a hard copy of the document, or send an e-mail request to GWA@CDRH.FDA.GOV to request hard or electronic copy. Please use the document number (1545) to identify the guidance you are requesting. Contains Nonbinding Recommen