Premature Closure of the Ductus Arteriosus

An indication as to whether the subject was born prior to 38 weeks gestation.

The birth of a baby before 37 weeks of pregnancy. In humans, a normal pregnancy lasts about 40 weeks. The risk of…

Each year, nearly 500,000 babies are premature, or preemies. That's 1 of every 8 infants born in the United States. A premature…

Premature onset of adrenal androgen-mediated secondary sexual characteristics.

The examination of data and information in an application for premarket review described in sections 505, 510(k), 513(f), 515, or 520(g) or…

A premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective as…