Determination of regulatory review period for purposes of patent extension; Therma Choice Uterine Ballon Therapy System. Food and Drug Administration, HHS. Notice.

The Food and Drug Administration (FDA) has determined the regulatory review period for Therma Choice5 Uterine Ballon Therapy System and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Commissioner of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that medical device.