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St Jude Medical's Puerto Rican pacemaker facility receives US FDA approval

St Jude Medical : 20 August, 2008  (Company News)
St Jude Medical has received US Food and Drug Administration (FDA) approval of the company's new facility in Arecibo, Puerto Rico, for the manufacturing of pacemakers and cardiac leads.
The 150,000ft2 facility, located in Arecibo's Santana Industrial Park, will initially be used to produce St Jude Medical pacemakers and cardiac leads for domestic and international markets, and the company plans to begin manufacturing implantable cardioverter defibrillators (ICDs) at the facility late this year. The new plant will expand the company's cardiac rhythm management manufacturing capacity and is expected to create at least 1,250 new jobs within the next three years.

The approval followed a six-month review that included an on-site evaluation by FDA inspectors.

'Our success in Puerto Rico reflects our commitment to the highest quality standards, so we are pleased to expand our manufacturing capabilities there,' said Daniel J Starks, chairman, president and chief executive officer of St Jude Medical. 'The expansion of our Puerto Rico operations enhances our ability to provide life-saving devices to people around the world.'

The expansion in Puerto Rico follows other recent expansions at two St Jude Medical manufacturing facilities in Sylmar, California, and Liberty, South Carolina, as well as the ongoing expansion at the company's global headquarters in St Paul, Minnesota, USA.

In 1987, St Jude Medical began operations in Puerto Rico with 25 employees at its current Caguas facility. The original 23,000 square-foot plant, which manufactured mechanical heart valves, has evolved with the company's continuous development of new cardiovascular products, tripling its size and expanding its scope to manufacture more than 220 models of cardiovascular and cardiac rhythm management products that are exported to countries around the world.

The Caguas site will continue to manufacture mechanical heart valves and Angio-Seal vascular closure devices, and also is expected to add new product lines in the future.
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