DVI resumes shipment of atherectomy catheter.INDIANAPOLIS--(HealthWire)--June 21, 1995--Guidant Corporation today reported that its subsidiary, Devices for Vascular Intervention, Inc. (DVI), has received United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval of its PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy supplement for its AtheroCath-GTO(R) atherectomy catheter that removes plaque occluding a coronary artery. DVI will now resume production and shipment of the GTO. In addition, DVI will continue to ship the SCA EX(TM) atherectomy catheter. Last month, the company voluntarily stopped shipment of the AtheroCath-GTO(R) pending a review by the FDA of information submitted by DVI covering certain modifications to the catheter. The product was not sold in the U.S. for approximately 30 days. ``Guidant is absolutely committed to regulatory compliance,'' said Ron Dollens, President of Guidant. ``Our customers and their patients deserve nothing less.'' A leader in the medical device industry, Guidant Corporation provides innovative, cost-effective products and services to the global cardiology and minimally invasive surgery minimally invasive surgery Laparoscopic surgery, see there. See Laparoscopic cholecystectomy. marketplaces. Guidant comprises Advanced Cardiovascular Systems, Inc. (ACS (Asynchronous Communications Server) See network access server. ), Cardiac Pacemakers, Inc. (CPI), Devices for Vascular Intervention, Inc. (DVI), Heart Rhythm Technologies, Inc. (HRT), and Origin Medsystems, Inc. CONTACT: Guidant Corporation, Indianapolis Emile S. Godfrey, 317/971-2030 |
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