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Boston Scientific: Plant FDA Compliant

...Guidant began recalling several thousand pacemakers and Company spokesman Paul Donovan said the company is still making steady progress in resolving that warning letter.

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This material may not be published broadcast, rewritten, or redistributed More On This Topic Companies: BSX -% String xsl=(String) application.getAttribute(com.forbes.cms.Constants.XSL_REP_KEY)+"/story_body_html_trans.xsl"; final TransformerFactory tFactory = TransformerFactory.newInstance(); final Transformer transformer = tFactory.newTransformer(new StreamSource(xsl)); final ByteArrayOutputStream bao = new ByteArrayOutputStream(); byte[] bytes = transformedStoryStr.getBytes(); ByteArrayInputStream input=new ByteArrayInputStream(bytes); InputStream myInput=(InputStream)input; try{ transformer.transform(new StreamSource(myInput), new StreamResult(bao)); }catch (Exception e){ e.printStackTrace(); } transformedStoryS...

Boston Scientific Passes FDA Inspection on MN. Plant

...Guidant began recalling several thousand pacemakers and The lifting of the warning letter technically allows the company to get FDA approval on devices made at the plant, as well as receive approvals for certificates needed to market devices made at the plant overseas.

However, Boston Scientific still faces a corporate-wide warning letter that prevents the company from receiving FDA approvals for new products.

Company spokesman Paul Donovan said the company is still making steady progress in resolving that warning letter.

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Boston Scientific Says US Lifts Device Sanctions (Update3)

...The stock rose the most in more than a year.

The sanctions had barred export or approval of new models of Paul, Minnesota.

The Food and Drug Administration lifted the restrictions after re-inspecting the plant and agreeing to quality-system improvements, the Natick, Massachusetts-based company said today in a statement.

Boston Scientific is the second-largest player in the $10 billion worldwide market for The FDA action removes a regulatory hurdle that has hobbled the company since it purchased Guidant Corp.

12 months ago for $27.5 billion after defeating Johnson & Johnson in a bidding war.

``That's good news for them because it lets them introduce new products, which helps keep them competitive in terms of market share,'' said Bruce Nudell, an analyst with Sanford C.

Bernstein and Co.

in New York, in a telephone interview today.

``The warning letter was a reminder of all the regulatory problems they had and was one more reason doctors would be reluctant to go back to the brand,'' he said.

Boston Scientific shares rose $1.19, or 7.9 percent, to $16.20 at 11:24 a.m.

in New York Stock Exchange composite trading.

It would be the biggest one-day percentage increase since February 2005.

The stock had fallen 30 percent in the 12 months through April 13.

Quality...

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