Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
US Nationwide distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2024