SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A

SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A is an FDA 510(k)-cleared medical device (K101968) manufactured by 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 September 14, 2010. Regulation: 8.