The FDA issued an early alert related to a catheter introducer kit issue from Johnson & Johnson’s Abiomed Heart Recovery unit ...
The FDA said today that J&J's Abiomed unit issued a warning recommending the removal of certain Impella CP sets with SmartAssist.
On reaching the enrollment target, ABIOMED plans to submit the compiled data and seek U.S. Food and Drug Administration (:FDA) approval for a Continuous Access Protocol (CAP). The approval would ...
Abiomed, Inc. ABMD recently received FDA pre-market approval (PMA) for its newest right heart pump — the Impella RP with SmartAssist. The FDA has deemed the new pump as safe and effective when it ...
DANVERS, Mass., (GLOBE NEWSWIRE) -- Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced it has received approval for implementation of a Continuous Access ...
The US Food and Drug Administration has confirmed that patients treated with Abiomed’s Impella RP system had a lower survival rate in a postapproval study than did those treated in preapproval ...
Impella RP Flex is implanted percutaneously through the internal jugular (IJ) vein, which provides the option for patient mobility while on support, and is designed to be easy to implant, with a ...
Abiomed has issued an urgent medical device correction for its Impella RP and Impella RP Flex series of heart pumps. In a letter sent to customers on January 27, Abiomed said the voluntary device ...
Abiomed, Inc. ABMD recently received FDA pre-market approval (PMA) for its newest right heart pump — the Impella RP with SmartAssist. The FDA has deemed the new pump as safe and effective when it ...
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