868.5610—Membrane lung for long-term pulmonary support.

(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.

Code of Federal Regulations

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

CFR

868.5610—Membrane lung for long-term pulmonary support.

Code of Federal Regulations