21 CFR 874.3820
§ 874.3820 Endolymphatic shunt.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3820, § 874.3820 Endolymphatic shunt, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90227
- Permanent ID
ys:prov:90227@1- SHA-256
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Full text
(a) Identification. An endolymphatic shunt is a device that consists of a tube or sheet intended to be implanted to relieve the symptons of vertigo. The device permits the unrestricted flow of excess endolymph from the distended end of the endolymphatic system into the mastoid cavity where resorption occurs. This device is made of polytetrafluoroethylene or silicone elastomer.
(b) Classification. Class II.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.