Article: Company files for IDE for rapid HIV test.(investigational device exemption)(Brief Article)

Article: BIOPLASTY SUBMITS INVESTIGATIONAL DEVICE ...
PR Newswire;  February 4, 1992 ;     700+ words ...BIOPLASTY SUBMITS INVESTIGATIONAL DEVICE EXEMPTION (IDE) FOR ITS MISTI GOLD BREAST IMPLANTS ... BIOP) announced today that it has filed an Investigational Device Exemption (IDE) with the United States Food and Drug ...

Article: POSSIS MEDICAL FILES INVESTIGATIONAL DEVICE ...
PR Newswire;  March 30, 1992 ;     678 words ...POSSIS MEDICAL FILES INVESTIGATIONAL DEVICE EXEMPTION APPLICATION MINNEAPOLIS, March 30 /PRNewswire ... its wholly owned subsidiary, has filed an Investigational Device Exemption (IDE) application with the U.S. Food ...

Article: ev3 Receives Investigational Device ...
PR Newswire;  December 6, 2004 ;     700+ words ... ... medical device company, has received an investigational device exemption (IDE) approval from the U.S. Food and ... SPIDER(TM) Embolic Protection device is an investigational device limited by federal (U.S.) law to investigational ...

Article: CryoLife, Inc. Files Investigational Device ...
PR Newswire;  November 28, 2000 ;     700+ words ... ... adhesives, announced that it has filed an Investigational Device Exemption (IDE) application with the U.S. Food ... S. under a FDA- approved Humanitarian Device Exemption (HDE) for use as an adjunct in the repair ...

Article: Investigational Device Exemption Application ...
Business Wire;  November 5, 2009 ;     700+ words ... ... CardioWest[TM] Total Artificial Heart, announced it has submitted an application to the FDA to conduct an Investigational Device Exemption (IDE) clinical study of the Freedom[TM] discharge driver, designed to power the Total Artificial ...

Article: investigational device exemption (IDE)
The Mosby Medical Encyclopedia;      175 words ...The Mosby Medical Encyclopedia 10-01-1996 investigational device exemption (IDE), an agreement through which the federal government permits testing of new medical devices. The ideas, procedures and ...

Article: Investigational device exemption application ...
AIDS Weekly;  December 1, 2003 ;     700+ words ... ... antibody tests for use with urine samples, announced that it is submitting an application with the FDA for an Investigational Device Exemption (IDE) for its HIV-1 lateral flow antibody Rapid Blood Test to be performed on whole blood. This represents ...