This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Olympic Cool-Cap ®
Manufacturer: Olympic Medical Corporation
Address: 5900 First Ave. So. , Seattle, Washington 98108
Approval Date: December 20, 2006
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040025a.pdf
What is it? The Olympic Cool-Cap ® is designed to provide selective head cooling with mild below normal body temperature cooling in term newborns. The main components are a cooling unit, a control unit, temperature probes, and a water filled cap.
How does it work? The device works by circulating water through the fitted cap and maintaining the cap water at an operator-specified temperature.
When is it used? The Olympic Cool-Cap is indicated for use in infants with clinical evidence of moderate to severe hypoxic-ischemic encephalopathy (HIE) (brain injury due to lack of oxygen), defined by specific criteria, to provide selective head cooling with mild below normal body temperature cooling.
What will it accomplish? Prevent or reduce the severity of neurologic injury associated with HIE.
When should it not be used?Infants with a birth weight of less than 1,800 grams, evidence of head trauma or skull fracture causing major intracranial bleeding, or imperforate anus.
Additional information: Summary of Safety and Effectiveness and labeling are available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040025