(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 870.3.
[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]