21 C.F.R. § 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
Title 21 - Food and Drugs
(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. [71 FR 7871, Feb. 15, 2006]
Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices
§ 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
