(a) Identification. A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.
(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 Sec. 870.3. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]