(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]