MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP

MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP is an FDA 510(k)-cleared medical device (K041317) manufactured by Medtronic Minimed. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 18, 2004. Regulation: 8.