April 17, 2007 — Boston Scientific Corp. said Monday that regulators have lifted a warning about quality-control problems at a Minnesota plant that makes defibrillators and pacemakers, enabling the company to resume seeking approval for new devices to correct abnormal heartbeats, the AP reported.
Shares of Boston Scientific rose nearly seven percent after the announcement, which clears up one of two quality control warnings the company faces from the FDA. 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 heart rhythm devices.
The FDA quality-control warning that has been lifted originated in December 2005, when regulators cited manufacturing and record-keeping problems at a then-Guidant-owned plant in St. Paul. Boston Scientific, Natick, ME, acquired that plant in April 2006 when it bought Guidant Corp. for $27 billion.
The warning at the St. Paul plant did not hold up any major new product approvals involving Guidant's line of defibrillators and pacemakers that Boston Scientific acquired last year.
But the 2005 warning did prompt 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.