DevicePMAs@therightstef:P950005_S041 JSONTXT 11 Projects

Approval for modified catheter designs to the 7fr celsius and 7fr ez steer ds catheters to create the 7.5fr 8 mm celsius fltr catheters. the changes being approved are the increased distal profile, larger curve profile, increased range of deflection, and increased deflectable tip diameter. the devices, as modified, will be marketed under the trade names bi-directional celsius fltr catheters (d-1359-xx-s) and uni-directional celsius fltr catheters (d-1355-xx-s) and are indicated for catheter-based cardiac electrophysiological mapping (stimulation and recording), and when used with the stockert 70 (with software version 001/033 or higher) for the treatment of type i atrial flutter in patients age 18 years of age or older.