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UPDATE 1-FDA lifts restrictions on Medtronic defibrillator
February 19, 2010 / 6:22 PM / 8 years ago

UPDATE 1-FDA lifts restrictions on Medtronic defibrillator

* FDA says external defibrillators can ship worldwide

* Says company has met quality control requirements

* Shares little changed

NEW YORK, Feb 19 (Reuters) - Medical device maker Medtronic Inc (MDT.N) said on Friday that the U.S. Food and Drug Administration has lifted restrictions on sales of its external defibrillators after declaring quality control problems had been rectified.

Medtronic’s Physio-Control unit, which manufactures the emergency devices used to restore a normal heart beat, said the FDA informed the company it can resume unrestricted worldwide shipments of its external defibrillators as it had “successfully met requirements for improvements to the quality system.”

Physio-Control in May of 2008 signed a consent decree with the FDA to address issues raised during inspections of the company’s quality system.

Under the terms of the agreement, Physio-Control was permitted to ship only a limited number of products to emergency care providers to meet public health and safety needs until quality system improvements were completed.

Those restrictions were lifted after the FDA notified the company that it had met requirements for improvements outlined by the health regulators.

“We dedicated significant energy and resources to establishing a new operating standard for our quality system and we are pleased it has met with the FDA’s approval,” Physio-Control President Brian Webster said in a statement.

“While this has been a difficult period in our recent history, we are very proud to reach this milestone with the FDA,” he added. (Reporting by Bill Berkrot; Editing by Steve Orlofsky)

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