CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 870—CARDIOVASCULAR DEVICES > SUBPART D—Cardiovascular Prosthetic Devices (§870.3250 to §870.3945) > 870.3545—Ventricular bypass (assist) device.

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.
(b) Classification. Class III (premarket approval).
(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

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]