Medtronic Inc. said Wednesday it had resolved issues at two manufacturing plants cited by a brace of U.S. Food and Drug Administration warning letters in 2009.
Resolving these citations clears a hurdle to approving new devices, including a new defibrillator.
The Fridley, Minn.-based med tech giant got slapped with an FDA warning in June 2009 following a December 2008 inspection of its Juncos, Puerto Rico manufacturing facility. The federal agency said the Juncos plant failed to correctly report problems with drug pumps.
Medtronic also received a November 2009 letter following an August 2009 inspection of its Mounds View, Minn. facility, which serves as headquarters for its heart rhythm business, its largest division by sales. The reasons for the warnings were not disclosed, according to a Wall Street Journal report, but fall under the general categories of timeliness of reporting, responding to and reviewing problems.
Medtronic can now seek final approval for new products, such as the next-generation Protecta implantable defibrillator, which have been held up by the manufacturing citations.
Medtronic's stock rose 0.76 percent to reach $39.94 in morning trading.
