Johnson & Johnson asked customers to quarantine and return affected products. A spokesperson said J&J conducted quality system audits as part of its integration of Abiomed that resulted in some field ...
The FDA said today that J&J's Abiomed unit issued a warning recommending the removal of certain Impella CP sets with SmartAssist.
For stabilized patients undergoing complex PCI, left ventricular unloading with an Impella CP microaxial flow pump ...
WASHINGTON, DC—Patients with STEMI complicated by severe cardiogenic shock do not derive a benefit from routine use of the Impella CP mechanical circulatory support (MCS) device during primary PCI, ...
DANVERS, Mass., Dec. 07, 2016 (GLOBE NEWSWIRE) -- Abiomed, Inc. (ABMD), a leading provider of breakthrough heart support and recovery technologies, today announced it has expanded its U.S. Food and ...
Massachusetts-based heart support technologies major, Abiomed Inc. (ABMD) recently received 510(k) approval from the U.S. Food and Drug Administration (:FDA) for its new Impella product dubbed Impella ...
Abiomed (NASDAQ: ABMD) announces the results of PROTECT III, the ongoing, prospective, single-arm FDA post-approval study for the PMA approval of Impella 2.5 and Impella CP in high-risk PCI. PROTECT ...
Danvers, MA-based ABIOMED, Inc.ABMD, a leading medical product developer, announced the expanded U.S. FDA pre-market approval (PMA) for the usage of Impella CP heart pump. The heart pump is used for ...
Massachusetts-based heart support technologies major, Abiomed Inc. ( ABMD) recently received 510(k) approval from the U.S. Food and Drug Administration (FDA) for its new Impella product dubbed Impella ...
Massachusetts-based heart support technologies major, Abiomed Inc. (ABMD) recently received 510(k) approval from the U.S. Food and Drug Administration (:FDA) for its new Impella product dubbed Impella ...
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