21 C.F.R. § 870.3535 Intra-aortic balloon and control system
Title 21 - Food and Drugs
(a) Identification. A intra-aortic balloon and control system is a device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle. (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. [45 FR 7907–7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart D—Cardiovascular Prosthetic Devices
§ 870.3535 Intra-aortic balloon and control system
