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Biotronik, Inc.
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AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP is an FDA 510(k)-cleared medical device (K021217) manufactured by Biotronik, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on April 30, 2002. Regulation: 8.