Medtronic resolves FDA warnings over 2 factories

Twin Cities-based Medtronic says it's resolved two warning letters from the Food and Drug Administration clearing the way for the introduction of new medical devices.

The warning letters were issued in 2009 and concerned problems at facilities in Mounds View and Puerto Rico. The FDA cited Medtronic for unsatisfactory procedures for preventing and identifying problems with devices, documenting those problems and notifying the FDA.

"The resolution of the warning letters is an important milestone for the company and also it removes a barrier to bringing some innovative new products to the market," said Brian Henry, a Medtronic spokesman.

While Medtronic worked to resolve issues raised in the warning letters, it could not introduce new products from the two manufacturing plants involved.

Henry said one of the new products that will be coming from the plants is a defibrillator that is less likely to deliver inappropriate shocks. The other is a nerve stimulation device.