St Jude Medical has said that it has received FDA approval for the company's new facility in Arecibo, Puerto Rico, for manufacturing pacemakers and cardiac leads.
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The 150,000 square-foot 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 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 the FDA inspectors.
Daniel Starks, chairman, president and CEO of St Jude Medical, said: “The expansion of our Puerto Rico operations enhances our ability to provide life-saving devices to people around the world.”
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