DevicePMAs@therightstef:P010068_S002 JSONTXT 13 Projects

Approval for modifications mad to the navistar ds 8mm tip deflectable diagnostic/ablation catheter approved under p010068 and the qwikstar 4 mm deflectable tip diagnostic/ablation catheter approved under p990025/s004. The device, as modified, will be marketed under the trade name qwikstar ds diagnostic/ablation catheter and is indicated for catheter based cardiac electrophysiological mapping (stimulation and recording) and when used with the stockert 70 rf generator (software version 1.033 or higher) for the treatment of type i atrial flutter in patients 18 years or older.