Company: BIOTRONIK Inc.. Date of Enforcement Report 8/19/2015 Class lI: PRODUCT PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle. Recall Number Z-2376-2015 REASON...Read More
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