Telectronics replacements for withdrawn Encor/Accufix pacer leads pending at FDA.
This article was originally published in The Gray Sheet
Executive Summary
TELECTRONICS REPLACEMENTS FOR ENCOR/ACCUFIX PACER LEADS are undergoing premarket review by FDA, the firm states. Two Maxim passive fixation (non-steroidal) atrial leads - one unipolar and one bipolar -- have been under 510(k) review by the agency since the applications were submitted in the first quarter, Telectronics says. A 510(k) also is pending for the firm's Secure active fixation (non-steroidal), bipolar, ventricular lead.
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