A multicenter study of the impella device for mechanical support of the systemic circulation in pediatric and adolescent patients
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Abiomed. Abiomed Impella therapy receives FDA approval for cardiogenic shock after heart attack or heart surgery [press release]. April 7 2016.
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FDA. Summary of Safety and Effectiveness Data (SSED) ‐ AMI/CS PCCS.http://www.accessdatafda.gov/cdrh_docs/pdf14/P140003S005B.pdf.
Premarket Assessment of Pediatric Medical Devices ‐ Guidelines for Industry and Food and Drug Administration Staff. Issued March 24 2014.http://www.fda.gov/RegulatoryInformation/Guidances/ucm089740.htm.