Ascent Healthcare Receives 510(k) Clearance on Medtronic TORQR CS Series Catheters.PHOENIX -- Ascent Healthcare Solutions (formerly Alliance Medical Corp. and Vanguard Medical Concepts) announced today that the Food and Drug Administration (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. ) has cleared Ascent's 510(k) to reprocess re·proc·ess tr.v. re·proc·essed, re·proc·ess·ing, re·proc·ess·es To cause to undergo special or additional processing before reuse. Verb 1. the TORQR([R]) CS Series EP catheters manufactured by Medtronic(1). Reprocessing Reprocessing may refer to:
Medtronic Cardio Rhythm Torqr Catheters are fixed curve devices intended for use in diagnostic electrophysiology electrophysiology /elec·tro·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je) 1. the study of the mechanisms of production of electrical phenomena, particularly in the nervous system, and their consequences in the living organism. 2. (EP) procedures. They record intracardiac intracardiac /in·tra·car·di·ac/ (-kahr´de-ak) within the heart. in·tra·car·di·ac adj. Within the heart. intracardiac within the heart. electrograms and temporary pacing associated with EP studies. "Through our predecessor companies, Ascent has been a leader in reprocessing a broad array of EP catheters for hospitals around the country," said Don Selvey, vice president of Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: Collectively, Ascent has safely reprocessed more than 50 million SUDs for over 1,700 healthcare facilities nationwide. Ascent expects to help its customers save in excess of $92 million in supply expenses in the coming year, which may be redirected to patient services. In addition, the company expects to eliminate over 7,000 tons of medical waste from the nation's landfills annually. (1) TORQR is a registered trademark of Medtronic, Inc. About Ascent Healthcare Solutions Ascent Healthcare Solutions, the leading independent third-party reprocessor of specific single-use medical devices (SUDs), has reprocessed more than 50 million SUDs for over 1,700 healthcare facilities nationwide. The company's primary reprocessing center and home office are in Phoenix, Ariz. with an additional reprocessing center in Lakeland, Fla. Ascent holds agreements with all leading national group purchasing organizations A group purchasing organization is an entity that leverages the purchasing power of a group of businesses to obtain discounts from vendors based on the collective buying power of the GPO members. Many GPOs are funded by administrative fees that are actually paid by the vendors. as well as numerous nationally recognized hospital integrated delivery networks that collectively represent more than 5,000 healthcare facilities. For more information about Ascent Healthcare Solutions, visit www.ascenthealthcaresolutions.com. |
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