(a)Identification. A pacemaker programmer is a device used to change noninvasively one or more of the electrical operating characteristics of a pacemaker.
(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 37573, June 22, 2012.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987]