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December 2019 Approvals Snapshot: Abbott Earns New Approval For CentriMag Circulatory Support System

 
• By Reed Miller

December’s new medical device approvals include the FDA approval of Abbott Laboratories’ CentriMag circulatory support system for postcardiotomy patients, MicroVention’s FRED system for wide-necked intracranial aneurysms and an expanded indication for Foundation Medicine’s FoundationOne CDx cancer-drug companion diagnostic.

Approved

The US Food and Drug Administration approved two original premarket approvals (PMA) and one panel-track PMA supplement in December 2019.

On 6 December, the agency approved a PMA for Abbott Laboratories Inc.’s CentriMag circulatory support system for patients who fail to wean from cardiopulmonary bypass following open-heart surgery....

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