21 CFR 870.2855
§ 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 870.2855, § 870.2855 Implantable Intra-aneurysm Pressure Measurement System, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89946
- Permanent ID
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Full text
(a) Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.
(b) Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See § 870.1 (e) for the availability of this guidance document.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.