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Current as of January 02, 2025 | Updated by Findlaw Staff
(a) Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
(b) Classification. Class II (performance standards).
Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-870-3470/
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