|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||DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, ORIGEN CRT-D, X4 CRT-D, INCEPTA TM ICD, ENERGEN TM ICD & PUNCTUA TM ICD|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of an alternate semi-automated 'thickness and loading' process step to the battery manufacturing line.