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February 20, 2013
16:07 EDTABMDAbiomed receives close-out letter from FDA
Abiomed announced that on February 19, Abiomed received a close-out letter from the FDA, Office of Compliance with respect to its previous FDA warning letter dated June 10, 2011. The close-out letter states that the FDA Office of Compliance has completed its evaluation of the corrective actions taken by Abiomed in response to the previously disclosed FDA warning letter and that the concerns cited in that letter appear to have been addressed.
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September 16, 2014
17:06 EDTABMDTrial results from Abiomed RECOVER RIGHT show survival rate of 73%
Abiomed announced clinical trial results from RECOVER RIGHT, an Investigational Device Exemption study of the Impella RP System. The clinical trial results demonstrated a survival rate of 73% in the overall patient population. Overall, the survival rate was 73% in the entire population at 30 days. Cohort A showed a survival rate of 83.3% and Cohort B had a 58.3% survival rate at 30 days.
September 15, 2014
07:21 EDTABMDHeart Failure Society of America to hold annual meeting
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