|Trade Name||LINOX TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||implantable cardioverter defibrillator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a lead based on the kentrox sl and linox sd icd leads with 0. 11 mm filaments in the lead tip conductor. The device, as modified, will be marketed under the trade name linox td implantable cardioverter defibrillator lead and is indicated for use in conjunction with a biotronik icd. Currently, data is not available regarding the use of these lead systems with icds of other manufacturers. Use of other icds may adversely affect sensing and/or therapy delivery.