* FDA says external defibrillators can ship worldwide
* Says company has met quality control requirements
* Shares little changed
NEW YORK, Feb 19 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
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
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)