21 CFR 870.3700
§ 870.3700 Pacemaker programmers.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.3700, § 870.3700 Pacemaker programmers, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89974
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Full text
(a) Identification. A pacemaker programmer is a device used to noninvasively change 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 PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 20, 2012, for any pacemaker programmer that was in commercial distribution before May 28, 1976, or that has, on or before September 20, 2012, been found to be substantially equivalent to any pacemaker programmer that was in commercial distribution before May 28, 1976. Any other pacemaker programmer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.