July 2 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.
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.
St. Jude sells pacemakers, implantable defibrillators,
artificial heart valves, stents and neurological products.
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)