(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.
Link to an amendment published at 77 FR 37576, June 22, 2012.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]