(Reuters) - St. Jude Medical Inc said the U.S. Food and Drug Administration notified the company that issues regarding its Sylmar, California-based manufacturing plant have been resolved.
The FDA last year had warned St. Jude of serious violations at the plant where the Durata and Riata leads for implantable defibrillators are made. Violations included a failure to validate testing methods. [ID:nL2N0D40KS]
Implantable heart defibrillators are small devices that are placed in the chest to correct irregular heart beat. Durata and Riata leads are wires that connect this device to the heart.
St. Jude first recalled Riata wires in 2011 after finding the insulation on them wore away prematurely. Last year, regulators questioned the design process for Durata leads.
The company has also been losing market share to competitors Medtronic Inc and Boston Scientific Inc in selling implantable defibrillators due to lingering concerns about problems with its lead wires. [ID:nL2N0KN1CT]
St. Jude sells pacemakers, implantable defibrillators, artificial heart valves, stents and neurological products. [ID:nBw22HsSja]
The company’s shares were little changed at $69.70 on the New York Stock Exchange on Wednesday morning.
Reporting by Natalie Grover and Amrutha Penumudi in Bangalore; Editing by Joyjeet Das