http://biotech.seekingalpha.com/article/32469The FDA has cleared its St. Paul cardiac rhythm-management device plant for operation. The plant was originally owned by Guidant, which Boston Scientific purchased for $27.5 billion last year. Guidant recalled 109,000 defibrillators in 2005 because of electrical and battery defects, prompting the FDA to inspect the plant.
The FDA then sent Guidant a warning letter about deficiencies at the plant in December 2005, all of which have now been resolved. Boston Scientific is now free to seek approvals for new devices in the $10 billion
a year global market for pacemakers and implantable cardio-verter defibrillators [ICDs]. It remains to be seen how successful and quickly Boston Scientific will be able to take back lost ICD market share.
Boston Scientific has yet to resolve a second warning letter about quality control problems at plants in Massachusetts, Minnesota, and Indiana.
