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In Brief: Biotronik

This article was originally published in The Gray Sheet

Executive Summary

Biotronik: Submits investigational device exemption submission to FDA for its Phylax 06 implantable cardioverter defibrillator system. The programmable, pectorally implantable device "offers multi-tiered therapy sequences in one of the smallest and lightest active housings within the 30 joule class," the firm states. The system includes Biotronik's SL-ICD single-pass, quadrapolar lead and the TMS 1000 programmer and monitoring device...
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