MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS is an FDA 510(k)-cleared medical device (K953417) manufactured by Cook Pacemaker Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 28, 1995. Regulation: 8.