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Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
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:
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-2020-D-0957.