|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||FORMIO, VITALIO, INGENIO, ADVANTIO, ACCOLADE, PROPONENT, ESSENTIO, & ALTRUA 2 PACEMAKERS|
|Applicant||BOSTON SCIENTIFIC CORPORATION|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a programming application software change for selected pacemakers and cardiac resynchronization therapy-pacemakers.