Tag: abbott

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Abbott Gets FDA Approval for TAVI System to Treat Aortic Stenosis

The FDA approved Abbott’s new transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis.

Abbot’s Heart Valve Repair Device May Malfunction, FDA Warns
Abbott Recalls Imaging Catheter for Potential Loose Catheter Marker Band
FDA Clears Abbott’s New Cardiac Mapping System to Treat Abnormal Heart Rhythms
Though Omicron Looms, Medical Device Industry Rebounds from Pandemic Lull
St. Jude Agrees to Pay $27M for Allegedly Selling Defective Heart Devices
FDA: Stop New Implants of Medtronic Ventricular Assist Device System

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Abbott’s Assurity, Endurity Pacemakers Recall Dubbed Class I Event by FDA

The U.S. FDA has categorized a recall of Abbot pacemakers caused by a manufacturing process that allowed moisture into the devices as a Class I event; some devices containing the fault could still be in use, reports MedTech Dive.

Abbott Buys St Jude Medical, Creating Cardiovascular Device Powerhouse

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Abbott Gets FDA Approval for TAVI System to Treat Aortic Stenosis

The FDA approved Abbott’s new transcatheter aortic valve implantation (TAVI) system, Navitor, to treat people with severe aortic stenosis.

Abbot’s Heart Valve Repair Device May Malfunction, FDA Warns
Abbott Recalls Imaging Catheter for Potential Loose Catheter Marker Band
FDA Clears Abbott’s New Cardiac Mapping System to Treat Abnormal Heart Rhythms
Though Omicron Looms, Medical Device Industry Rebounds from Pandemic Lull
St. Jude Agrees to Pay $27M for Allegedly Selling Defective Heart Devices
FDA: Stop New Implants of Medtronic Ventricular Assist Device System