FDA-Device2023-12-13Class II
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Abiomed, Inc.
Hazard
Pump not detected as connected to controller due to software issue.
Sold states
US: AZ, CA, FL, NY & VA.
Manufactured in
24 Cherry Hill Dr, Danvers, MA, United States
Products
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0441-2024Don't want to check this manually?
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