Defibrillators

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.

It also has a facility in Marlboro.

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 FDA move immediately cleared Boston Scientific to go ahead with four software upgrades to existing heart rhythm devices, Donovan said.

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

Paul ...

Until the underlying issues are resolved, the FDA will not approve key new products.Boston Scientific acquired Guidant for $27 billion soon after the FDA issued its warning, and since then has sunk significant resources into fixing Guidant's manufacturing and quality problems.

Chief executive Jim Tobin has said he is spending as much time at Guidant's Minnesota facility as he does at Boston Scientific's headquarters ."Since I run the company, I get to appoint who runs Guidant, so I appointed me," he told the Globe in January.In November and December, a year after issuing the Guidant warning, FDA officials re-inspected Guidant's facility, assessed new quality-control systems put in place by Boston Scientific, and did not observe any problems, the company said yesterday."We are very pleased with the FDA's conclusion," Tobin said yesterday.A spokeswoman for the FDA said the issues raised in the warning "appear to have been adequately addressed," and the agency will continue to monitor Guidant's products and recalls.Still in force, however, is a companywide warning letter Boston Scientific received from the FDA in January 2006.

That letter applies to its drug-coated stent business and the rest of the pre-Guidant areas of the company.

Executives have s...