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Electronic Code of Federal Regulations

e-CFR data is current as of February 21, 2020

Title 21Chapter ISubchapter HPart 870Subpart C → §870.2855


Title 21: Food and Drugs
PART 870—CARDIOVASCULAR DEVICES
Subpart C—Cardiovascular Monitoring Devices


§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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