|Trade Name||ADVANTIO, INGENIO, VITALIO, FORMIO PGS|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of a deburring operation and additional monitoring during the manufacturing of case halves for the devices.