SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM

SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM is an FDA 510(k)-cleared medical device (K851365) manufactured by Sorin Biomedica, Fiat, USA, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 2, 1985. Regulation: 8.