MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S

MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S is an FDA 510(k)-cleared medical device (K090114) manufactured by Oscor, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 3, 2009. Regulation: 8.