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 ...

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