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J&J s Abiomed lands FDA warning letter over Impella heart pumps

J&J s Abiomed lands FDA warning letter over Impella heart pumps
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United statesAbiomed impellaAbiomed danversJohnson medtechImpella connectFierce medtech

J&J s Abiomed recalls Impella again due to potential TAVR clashes

Johnson & Johnson's Abiomed unit has issued another recall for some of its Impella heart pumps.

Abiomed impellaSmart assist

Leaky Impellas Recalled; Andexanet Alfa s Brain Bleed Win; Estrogen Pills & High BP

Recent developments of interest in cardiovascular medicine

United statesDaiichi sankyoAbiomed impellaNicole louYork heart associationJournal of the american heart associationJournal of the american college cardiologySmartassist systemCardiovascular imagingEuropean heart journalAmerican heart associationNew york heart associationAmerican collegeLightning boltInternal medicineMedpage today

Abiomed wins FDA nod for Impella ECP pivotal heart pump trial

Abiomed (Nasdaq:ABMD) announced today that the FDA approved the version of Impella ECP for its upcoming pivotal trial.

Johnson medtechMike minogueMassachusetts based abiomedAmir kakiJohn hospitalAbiomed impella

FDA Tweaks Impella Indications on Basis of Post-Approval Study

The updated indication tightens the description of eligible patients on the basis of post-approval study results but in line with premarket study entry criteria.

Drug administrationAbiomed impellaHeart failureUs food and drug administrationNited states food and drug administrationMyocardial infarctionOrgan failureVentricular assist deviceEchanical cardiac assistEchanical cardiac supportVad left ventricle assist deviceEft ventricle assist device lvad

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