|Trade Name||LINOX S & LINOX T 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 leads based on the linox sd and linox td leads with one shock coil instead of two shock coils. The devices, as modified, will be marketed under the trade names linox s implantable cardioverter defibrillator (icd) lead and linox t implantable cardioverter defibrillator lead and are 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.