Defibrillators

Shares were up 7.5% at $16.14 in afternoon trading.

The FDA had issued a warning letter to Guidant on Dec.

22, 2005, after an inspection showed deficiencies in its quality-control systems.

The plant was reinspected between November 9 and December 7 by the FDA and found in compliance, the company said.

The resolution of the warning letter will enable Boston Scientific to pursue regulatory clearance of any new pacemakers or ICDs.

"We are very pleased with the FDA's conclusion," said Jim Tobin, chief executive officer of Boston Scientific.

"This achievement is the result of a lot of hard work by employees across our [cardiac rhythm-management] organization.

"The improvements made to our CRM quality system demonstrate our ongoing commitment to deliver the highest quality products to physicians and the patients they serve," Tobin added.

Guidant ICD sales have been under heavy pressure over the past two years due to a string of high-profile recalls, with an additional one issued last week.

No deaths or injuries were reported with the last recall, which involved batteries running out prematurely in some of the devices.

ICDs are defibrillator devices that are implanted in the chest to help regulate irr...

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