|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||7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM, 7F CELCIUS THERMOCOOL CATHETER WITH THERMMISTOR|
|Classification Name||cardiac ablation percutaneous catheter|
|Applicant||BIOSENSE WEBSTER, INC.|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an alternate supplier for the extrusion and braiding process for the family of products.