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Alliance Medical Corporation Receives 510k Clearance for Diamond Drill Burs; First Reprocessor 510k Clearance Since SVS Conclusion.


PHOENIX, Ariz. -- Alliance Medical Corporation (Alliance), a leading reprocessor of single-use medical devices (SUDs), today announced U.S. 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.
) clearance of Alliance's reprocessed diamond bur drill bits. This marks the first 510(k) clearance by the FDA for a reprocessed device without the need for a supplemental validation submission (SVS SVS - OS/VS2 ) as directed by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA MDUFMA Medical Device User Fee and Modernization Act ).

"Alliance commends the FDA for their continued dedication to ensuring patient safety and providing a safe and effective alternative to high-priced medical supplies," said Rick Ferreira, president of Alliance Medical Corporation. "The heightened review by the FDA is further evidence that reprocessed devices are at least as safe as other medical devices and enable Alliance to continue to provide desperately needed supply cost-savings for our hospital partners."

"With this new 510(k) clearance Alliance has again demonstrated our commitment to meeting the FDA's requirements for reprocessed medical devices as we continue to grow our product under the FDA's extremely heightened oversight," added 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:
 for Alliance Medical.

The new clearance covers models by Linvatec, MicroAire, Zimmer, Anspach and Stryker. These drill bits are used in surgery to cut and shape bones. The FDA's clearance 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.
 these drill bits allows Alliance Medical to provide greater savings opportunities for their hospital partners.

Having safely reprocessed more than twelve million SUDs, Alliance is one of the industry's most trusted device reprocessing Reprocessing may refer to:
  • Nuclear reprocessing
  • Recycling
 companies, providing hands-on support for customers. Alliance employs clinically trained and experienced service technicians and account executives who utilize its clinically focused, three-phased client support program, Assessment, Implementation and Management (AIM), to set up and manage the most efficient and effective SUD SUD 1. Substance use disorder 2. Sudden unexpected or unexplained death. See Sudden unexplained nocturnal death.  reprocessing program. The savings health care facilities achieve as a result can be used for vital patient services, new medical technology and nursing salaries, all of which lead to improved patient care.

About Alliance Medical Corporation

Alliance Medical Corporation (Alliance) is a leading reprocessor of specific single-use medical devices (SUDs) and has safely reprocessed more than 12 million SUDs, saving hospitals and surgery centers in excess of $150 million. Alliance goes beyond providing technically superior medical device reprocessing services to deliver guaranteed maximum supply-cost savings to leading healthcare organizations. Alliance is differentiated by our unwavering partnership commitment, clinical implementation expertise and dedicated field associates which together ensure that we exceed our partners' goals and expectations. The company's services focus on reducing supply costs of hospitals and surgery centers suffering from shrinking reimbursements and increasing costs. Alliance has agreements with leading national group purchasing organizations, alliances and supply chain service firms, including VHA VHA Veterans Health Administration
VHA Variable Housing Allowance
VHA Villages Homeowners Association
VHA Voluntary Hospitals Association
VHA Virtual Home Agent
VHA Very High Altitude
VHA Vapor Hazard Area
VHA Vermont Holstein-Friesian Association
, Broadlane and University HealthSystem Consortium (UHC UHC UnitedHealthcare
UHC United Health Care
UHC University Hospitals of Cleveland
UHC United Hitech Corporation
UHC Udvar-Hazy Center (National Air and Space Museum)
UHC University Health/System Consortium
UHC Unburned Hydrocarbons
), as well as a number of nationally recognized hospital integrated delivery networks, including Banner Health Banner Health is a non profit health system based in Phoenix, Arizona. The health system is one of the largest employer’s in the state - employing over 27,000 employees.  and Henry Ford Health System that collectively represents more than 4,000 healthcare facilities. For more information about Alliance Medical Corporation, visit www.alliance-medical.com; or call 888-888-3433.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Dec 13, 2004
Words:485
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