press_archive2005.html -
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Published on: 10/8/2008
Last Visited: 7/8/2007
To obtain further information and/or to receive an information pack, please contact Gerard Brett or Liam Mulloy at 091 861611 or e-mail us on liam.mulloy@zerusa.com.
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Contact: Gerard BrettPhone Number: +353-91-863061
December 3, 2005 - Zerusa Limited Announces United States Food & Drug Administration Marketing Clearance for the Guardian Hemostasis Valve
Galway, Ireland, December 3, 2005.Zerusa Limited announced today that it has received United States Food & Drug Administration (FDA) 510(k) Marketing Clearance for its Guardian hemostasis valve.The Company will be implementing a market evaluation plan to assess the Guardian in the U.S. market.Upon completion of market evaluation cases the Company plans to stage geographical introductions within the U.S.
"We are very pleased to receive U.S. FDA Marketing Clearance for our first product, the Guardian hemostasis valve" said Gerard Brett, Chief Executive Officer of Zerusa Limited.
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Contact: Gerard BrettPhone Number: +353-91-863061
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Gerard Brett, CEO of Zerusa, said: "We're delighted to have been chosen as the regional winner of the Seedcorn competition for Connacht.
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Contact: Gerard BrettPhone Number: +353-91-863061
September 30, 2005 - Zerusa Limited Announces thirty two European Union Clinical Cases Completed with the Guardian Hemostasis Valve
Galway, Ireland, September 30, 2005.Zerusa Limited announced today that it has now completed thirty two successful human cases involving the Guardian hemostasis valve in the European Union.
"The Guardian has proven to be an exciting new entrant into the hemostasis valve market.Interventional cardiologists have favorably commented on the Guardian's time saving operation and ease-of-use and its ability to significantly reduce the amount of blood within the surgical field.We are excited about the Guardian's prospects within the European market and other worldwide markets for the future," said Gerard Brett, Chief Executive Officer of Zerusa Limited.
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Contact: Gerard BrettPhone Number: +353-91-863061
July 29, 2005 - Zerusa Limited Announces Receipt of the CE Mark for the GuardianĂ” hemostasis valve for use in Interventional Procedures.
Galway, Ireland, July 29, 2005.Zerusa Limited announced today that it has received the CE Mark for its Guardian device, a next generation hemostasis valve.The Company plans to launch the product in European and other international markets.
"We are very pleased to receive European CE Mark approval for our first product, the Guardian" said Gerard Brett, Chief Executive Officer of Zerusa Limited.
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Contact: Gerard BrettPhone Number: +353-91-863061
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Contact: Gerard BrettPhone Number: +353-91-863061