|Trade Name||LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS|
|Classification Name||permanent defibrillator electrodes|
|Generic Name||implantable cardioverter defibrillator|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a new model to the linox smart icd lead family. This new model will be marketed under the trade name linox smart s dx icd lead and indicated for use in the right ventricle of patients for whom implantable cardioverter defibrillators are indicated; it can only be used with the lumax vr-t dx icd as a system. The lead incorporates two atrial sensing rings that replace the svc coil; in addition, an is-1 connector was added for the atrial sensing rings and the df-1 connector for the svc coil was removed.