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

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§ 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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United States Code

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 870 after this date.

  • 2015-10-21; vol. 80 # 203 - Wednesday, October 21, 2015
    1. 80 FR 63671 - Medical Devices; Cardiovascular Devices; Classification of the Coronary Vascular Physiologic Simulation Software Device
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 21, 2015. The classification was applicable on November 26, 2014.
      21 CFR Part 870