
Tyrx Pharma, Inc.
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PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 is an FDA 510(k)-cleared medical device (K063091) manufactured by Tyrx Pharma, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 2008. Regulation: 8.