Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling

Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling is an FDA 510(k)-cleared medical device (K153041) manufactured by Integra LifeSciences Corporation. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 13, 2016. Regulation: 8.