DevicePMAs@therightstef:P020025_S036 JSONTXT 13 Projects

Approval for blazer prime xp catheter design modifications, material packaging, labeling changes, and addition of accessories: intellatip mifi cable, filter module, and reference cable for the intellatip mifi family of catheters. the device, as modified, will be marketed under the trade name intellatip mifi xp ablation catheter and is indicated for use with the bsc maestro 3000 cardiac ablation controller and accessories for the treatment of sustained or recurrent type i atrial flutter in patients age 18 or older. the bsc high power cardiac ablation controller and accessories are indicated for use in conjunction with standard and high power catheters for cardiac ablation procedures.