§ 870.2855. Implantable Intra-aneurysm Pressure Measurement System.
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/us/cfr/t21/s§ 870.2855·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]