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870.3545—Ventricular bypass (assist) device.
(a) Identification.
A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
(c) Date PMA or notice of completion of a PDP is required.
No effective date has been established of the requirement for premarket approval. See § 870.3.
Code of Federal Regulations
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