Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions
FDA has developed this guidance document to assist industry in preparing premarket notification submissions for Coronary and Carotid Embolic Protection Devices. These devices are designed to capture and remove embolic material that may be dislodged during the interventional treatment of carotid arteries or saphenous vein bypass grafts with the intention of reducing the incidence of adverse cardiac or cerebrovascular events. We recommend that members of industry and FDA staff who perform or review clinical and non-clinical evaluations and prepare labeling of coronary and carotid embolic protection devices should use this guidance.
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.