Defibrillators

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 in 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 Arden Hills facility.The warning at the plant did not hold up any major new product approvals involving Guidant's line of Read more...