21 CFR 870.3850
§ 870.3850 Carotid sinus nerve stimulator.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 870.3850, § 870.3850 Carotid sinus nerve stimulator, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89979
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Full text
(a) Identification. A carotid sinus nerve stimulator is an implantable device used to decrease arterial pressure by stimulating Hering's nerve at the carotid sinus.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any carotid sinus nerve stimulator that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a carotid sinus nerve stimulator that was in commercial distribution before May 28, 1976. Any other carotid sinus nerve stimulator shall have an approved PMA or a 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.