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Boston Scientific Passes FDA Inspection

... Shares of Boston Scientific rose nearly 8 percent after the announcement, which clears up one of two quality control warnings the company faces from the Food and Drug Administration.

The one that is still pending, dating from January 2006, involves problems with systems to detect and respond to potentially defective and unsafe products other than so-called heart rhythm devices.

The quality-control warning that's now lifted dates to December 2005, when regulators cited manufacturing and record-keeping problems at a plant in St.

Paul, Minn.

The company, based in Natick, Mass., acquired that plant in April 2006 when it bought Guidant Corp.

for $27 billion.

The 2005 warning prompted Boston Scientific to revamp systems to detect product defects and other problems.

The FDA re-inspected the plant last November and again in December, and found no problems, the company said.

"The principal benefit will be to allow new CRM (cardiac rhythm management) products to be considered for approval," said Paul Donovan, a spokesman for Boston Scientific.

The decision also means Boston Scientific is eligible to receive certificates needed to conduct overseas marketing for devices made at the St.

Paul facility.

The warning at the St.

Paul plant did not hold up any major new product approvals involving Guidant's line of

Boston Scientific: FDA Lifts One Warning

...Shares of Boston Scientific rose nearly 8 percent after the announcement, which clears up one of two quality control warnings the company faces from the Food and Drug Administration.

The one that is still pending, dating from January 2006, involves problems with systems to detect and respond to potentially defective and unsafe products other than so-called heart rhythm devices.

The quality-control warning that's now lifted dates to December 2005, when regulators cited manufacturing and record-keeping problems at a plant in St.

Paul, Minn.

The company, based in Natick, Mass., acquired that plant in April 2006 when it bought Guidant Corp.

for $27 billion.

The 2005 warning prompted Boston Scientific to revamp systems to detect product defects and other problems.

The FDA re-inspected the plant last November and again in December, and found no problems, the company said.

"The principal benefit will be to allow new CRM (cardiac rhythm management) products to be considered for approval," said Paul Donovan, a spokesman for Boston Scientific.

The decision also means Boston Scientific is eligible to receive certificates needed to conduct overseas marketing for devices made at the St.

Paul facility.

The warning at the St.

Paul plant did not hold up any major new product approvals involving Guidant's line of

Icahn says will not push opposing MedImmune slate

... This has been served from cache Request served from apache server: s263567nj2el43.uswhwk6.savvis.net Cached on Mon, 16 Apr 2007 15:00:10 GMT and will expire on Mon, 16 Apr 2007 15:59:39 GMT Tomcat Server /s263567nj2el64.uswhwk6.savvis.net/ Icahn says will not push opposing MedImmune slate Reuters Article Icahn says will not push opposing MedImmune slate Mon Apr 16, 2007 8:58AM EDT Related News Company News MedImmune hires Goldman to find buyer for company US STOCKS-Wall St up on M&A, retail sales; Apple falls late US STOCKS-Wall St rallies on M&A and retail sales US STOCKS-Wall St ends higher on retail sales and M&A US STOCKS-Indexes up as rate fears ease, M&A boosts tech Market View MEDI.O Last: Change: Revenue (ttm): EPS: Market Cap: Time: Stock Details Company Profile Analyst Research Related News Videos Internationa...

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