|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER|
|Classification Name||cardiac ablation percutaneous catheter|
|Applicant||BIOSENSE WEBSTER, INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in calibration and calibration check manufacturing processes pi-008-01 and pi-008-02 to incorporate the catheter calibration system as an alternative to the helmholtz calibration system.