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GUIDANCE DOCUMENT

Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions Guidance for Industry and FDA Staff February 2008

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center 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.

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Submit Comments Online

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-2020-D-0957.

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