---
kind: "section"
citation: "21 C.F.R. § 870.2855"
title: "21"
number: "870.2855"
heading: "Implantable Intra-aneurysm Pressure Measurement System."
url: "https://uscodex.org/cfr/21/870.2855"
---

# §870.2855. Implantable Intra-aneurysm Pressure Measurement System.

- (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)](/cfr/21/870.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[71 FR 7871, Feb. 15, 2006]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 45 FR 7907, Feb. 5, 1980, unless otherwise noted.

### Amendments

[71 FR 7871, Feb. 15, 2006]