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]

Title 21 published on 2014-04-01

no entries appear in the Federal Register after this date.

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United States Code

Title 21 published on 2014-04-01

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

  • 2014-09-15; vol. 79 # 178 - Monday, September 15, 2014
    1. 79 FR 54927 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed order.
      Submit either electronic or written comments on the proposed order by December 15, 2014. See section XII for the effective date of any final order that may publish based on this proposed order.
      21 CFR Part 870