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SynchroMed brings no pain relief for Medtronic

Medtronic has agreed to the US FDA’s demands to stop making and distributing the SynchroMed II implantable infusion pumps, except in limited circumstances, until the company corrects quality system violations identified by the agency.

Medtronic has agreed to the US FDA’s demands to stop making and distributing the SynchroMed II implantable infusion pumps, except in limited circumstances, until the company corrects quality system violations identified by the agency.

The consent decree and the FDA’s complaint against Medtronic were filed in a US district court on 27 April. The former document names Medtronic CEO Omar Ishrak and Thomas Tefft,...

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