Defibrillators

22, 2005.

The FDA reinspected the St.

Paul, Minnesota, plant between Nov.

9 and Dec.

7.Boston Scientific still must resolve a second warning letter affecting other facilities.The resolution of the FDA problems should put Boston Scientific in a better position to regain share in the market for implantable cardioverter Boston Scientific warns of heart battery Shares of Boston Scientific, which faces competitive threats to several top franchises, remain down about 6 percent this year.

They were up $1.13 to $16.14, more than 7 percent in midday New York Stock Exchange trading - far off the $45-a-share levels they reached in 2004."The stock has been so beaten down and battered for so long, investors seem to be looking for any excuse to get involved at these levels," RBC Capital Markets analyst Phil Nalbone said.The FDA issued the ...

The FDA reinspected the St.

Paul, Minnesota, plant between November 9 and December 7.Boston Scientific still must resolve a second warning letter affecting other facilities.

The resolution of the FDA problems should put Boston Scientific in a better position to regain share in the market for implantable cardioverter They were up $1.13 at $16.14 in midday New York Stock Exchange trading - far off the $45-a-share levels they reached in 2004."The stock has been so beaten down and battered for so long, investors seem to be looking for any excuse to get involved at these levels," RBC Capital Markets analyst Phil Nalbone said.

Continued...

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The FDA re-inspected Guidant's cardiac rhythm management or CRM facility in St.

Paul, Minnesota between November 9 and December 7, 2006 and noted no observations.

The re-inspection included an assessment of Natick, Massachusetts-based Boston Scientific's implementation of quality system improvements in response to the warning letter.

Due to the sanctions, export or approval of new models of Paul, Minnesota had been barred.

The U.S.

regulators had said earlier that loose particles inside the crystal components of the device caused 35 confirmed failures of the Insignia line of pacemakers.

While patients were not informed of the possibility of failure while using Insignia pacemakers, the company also failed to warn doctors in time about software glitches that led to some pacemakers quitting.

A total of 49 Insignia failures were cited by the FDA, which criticized Guidant's quality-control system as well as record-keeping.

Commenting on the development, Jim Tobin, President and Chief Executive Officer of Boston Scientific, said: "We are very pleased with the FDA's conclusion.

This achievement is the result of a lot of hard work by employees across our CRM organization.

The improvements made to our CRM quality sy...