<span id="midArticle_start"/> (Reuters) - Medtronic Plc has agreed toresolve U.S. regulators' allegations it violated qualitystandards for making its SynchroMed implantable infusion pump,which delivers medications to cancer patients and others withchronic pain.
<span id="midArticle_0"/>The medical device maker and two top executives agreed toterms of a consent decree with the U.S. Food and DrugAdministration requiring changes to the product's manufacturingprocess, the U.S. Department of Justice said in a statement. Theagreement includes Medtronic Chief Executive Omar Ishrak andSenior Vice President Thomas Tefft.
<span id="midArticle_1"/>Medtronic said it is focused on implementing design changesto the pump and improving its neuromodulation quality system.
<span id="midArticle_2"/>The company said it is not required to retrieve any productscurrently in use, and patients using the system do not need tochange their course of therapy or have the pump removed.
<span id="midArticle_3"/>The DOJ filed a complaint and the consent decree in U.S.district court in Minnesota, which must approve the agreement. (Reporting by Susan Kelly in Chicago)
<span id="midArticle_4"/>
<span id="midArticle_0"/>The medical device maker and two top executives agreed toterms of a consent decree with the U.S. Food and DrugAdministration requiring changes to the product's manufacturingprocess, the U.S. Department of Justice said in a statement. Theagreement includes Medtronic Chief Executive Omar Ishrak andSenior Vice President Thomas Tefft.
<span id="midArticle_1"/>Medtronic said it is focused on implementing design changesto the pump and improving its neuromodulation quality system.
<span id="midArticle_2"/>The company said it is not required to retrieve any productscurrently in use, and patients using the system do not need tochange their course of therapy or have the pump removed.
<span id="midArticle_3"/>The DOJ filed a complaint and the consent decree in U.S.district court in Minnesota, which must approve the agreement. (Reporting by Susan Kelly in Chicago)
<span id="midArticle_4"/>
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