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Oscor, Inc.
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PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS is an FDA 510(k)-cleared medical device (K013339) manufactured by Oscor, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 7, 2001. Regulation: 8.