Interventional device developer Abbott Vascular Devices (AVD), a subsidiary of Abbott Laboratories of Abbott Park, IL, said it has submitted an application for premarket approval (PMA) for its StarClose vascular closure system to the Food and Drug Administration.
AVD said it submitted the PMA in February, based on its completion of the CLIP (clip closure in percutaneous procedures) clinical study, which compared the safety and effectiveness of StarClose versus manual compression to control bleeding following a catheterization procedure.
StarClose received CE Mark certification in February 2004, and the product was officially launched outside of the U.S. in 2004, the company said.
By AuntMinnie.com staff writers
April 13, 2005
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