Defibrillators

CEO Tobin and his team have been trying to turn the company around since.

Now, after the Food and Drug Administration warned Guidant on December 22, 2005 about deficiencies at a facility that makes heart rhythm devices, the agency re-inspected Guidant's facility in St.

Paul, Minnesota between November 9 and December 7, 2006, assessing how well the company had addressed the recent warning.

"We are very pleased with the FDA's conclusion," CEO Tobin said in a press release Apr.

16.

"The improvements made to our CRM quality system demonstrate our ongoing commitment to deliver the highest quality products." Investors bid up Boston Scientific's stock 6.6% to $16 per share on the New York Stock Exchange Apr.

16.

"While we believe the company continues to struggle in recapturing share in the pacemaker and implantable defibrillator markets, we view this development as a step in the right direction that will allow BSX to launch new CRM [heart-monitoring] products without restriction," Standard & Poor's equity analyst Robert Gold said in a research note.

(S&P, like BusinessWeek.com, is owned by The McGraw-Hill Companies.) After acquiring Guidant, Tobin brought in new people to head research and development, quality, and manufacturing, as well as...

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