Letterkenny's Boston Scientific plant has received approval from the US Food and Drug Administration to manufacture its 'Ultra 2 Coronary Cutting Balloon' device for distribution in the US.
This approval will now allow the company to sell the medical device in the US as well as continuing to sell it outside the US.
The Letterkenny plant manager, Justin Walsh, said it was very good news for the Co Donegal facility.
'In 2004 we announced plans to consolidate the top line assembly of several products which were being manufactured at Boston Scientific sites in Letterkenny and California into Letterkenny. Since July 2004, we have increased our headcount in Letterkenny from 54 to 120,' he said.
The Ultra 2 Coronary Cutting BalloonTM is an angioplasty device used in the treatment of coronary artery disease.
Boston Scientific Letterkenny is one of four Boston Scientific facilities in Ireland. The other sites are Galway, Tullamore and Cork. Boston Scientific employs over 3,500 people in Ireland.
