|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||EASYTRAK 2 AND EASYTRAK 3 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD,ACUITY SPIRAL LEAD|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the internal inspection requirements for moisture content of the two part medical adhesive.