|Trade Name||MODEL 6960 SWITCHABLE ECG PATIENT CABLE|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||ecg cable|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approva for a switchable ecg cable that allows the clinician to display and record ecg signals from seven different vectors (leads) without moving the ecg electrodes that are attached to the patient. The device, as modified, will be marketed under the trade name model 6960 switchable ecg cable and is indicated for use as an accessory to the models 2950 and 2901 programmer/recorder/monitors (prms).