Angeion's Lyra 2020
This article was originally published in The Gray Sheet
Premarket approval application supplement is submitted to FDA for the 47 cc, 88 gram implantable cardioverter defibrillator and the firm's AngePass 4040 and 4080 leads. Approval is expected in the first or second quarter of 1999, the Minneapolis firm says. The ICD is about 25% smaller than Angeion's Sentinel ICD, which was approved in August. Clinical trials to support a PMA supplement for a next-generation 2030 version of the Lyra are expected to begin in the first quarter while trials of the 2100 dual chamber ICD are expected to start before the end of 1999, Angeion notes
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