Confirm Rx Insertable Cardiac Monitor

Confirm Rx Insertable Cardiac Monitor is an FDA 510(k)-cleared medical device (K202876) manufactured by Abbott (St. Jude Medical). This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 2020. Regulation: 8.