21 C.F.R. § 870.3610 Implantable pacemaker pulse generator.
Title 21 - Food and Drugs
(a) Identification. An implantable pacemaker pulse generator is a device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device is used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders. This device includes triggered, inhibited, and asynchronous devices implanted in the human 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. [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
§ 870.3610 Implantable pacemaker pulse generator.
