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Electronic Code of Federal Regulations

e-CFR data is current as of February 21, 2020

Title 21Chapter ISubchapter HPart 870Subpart D → §870.3470


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices


§870.3470   Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(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).

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