Code of Federal Regulations Title 21. Food and Drugs § 21.870.2855 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) for the availability of this guidance document.