|Trade Name||TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS|
|Classification Name||permanent pacemaker electrode|
|Generic Name||permanent pacemaker electrode|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the use of thermedics tecothane t11075d-m for molded polyurethane components as a replacement for pellethane 2363-75d. Fda also acknowledges your marketing of the tenril dx model 1388t/c lead, which is identical to the approved model 1388t lead, except that it is packaged only with the clip-on tool accessory.