|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||FINISHING WIRE UNIVERSAL|
|Classification Name||defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifications to the finishing wire cap section of the commercially available finishing wire universal which will allow it to be compatible with the is-1 terminal pin as well as the lv-1 terminal pin of the easytrak leads. The device, as modified, will be marketed under the trade name finishing wire universal, models 6001-6007 and is indicated for use with guidant coronary vendus leads.