DevicePMAs@therightstef:P920015_S021 JSONTXT 11 Projects

Approval for the model 6996 sq lead system and the 6996t tunneling tool. The model 6996 sq lead system is for single, long-term subcutaneous use and is intended for use in patients in which implantable cardioverter defibrillators (icd) are indicated. The lead is intended for use if a standard icd system with one or two transvenous leads has not been efficacious in providing acceptable dft measurements. The model 6996 sq lead is intended for use only with the following systems: a medtronic icd featuring a connector block with at least two df-1 connector ports; and a medtronic right ventricular lead for defibrillating/pacing/sensing. In addition, a third defibrillation lead, such as any medtronic svc lead, may be used with a lead adaptor.