21 CFR 870.2855 - Implantable Intra-aneurysm Pressure Measurement System.

§ 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.

[ 71 FR 7871, Feb. 15, 2006]

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