§ 868.5610 - Membrane lung for long-term pulmonary support.  


Latest version.
  • (a) Identification. A membrane lung for long-term pulmonary support is a device used to provide to a patient extracorporeal blood oxygenation for longer than 24 hours.

    (b) Classification. Class III (premarket approval).

    (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See §868.3.

    [47 FR 31142, July 16, 1982, as amended at 52 FR 17735, May 11, 1987]