|Trade Name||PRIZM & VITALITY PG CONFIENT ICD|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||cardiac resynchronization therapy defibrillator (crt-d) system|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the latitude communicator software (model 6482) version 2. 1 and related system software (model 6488) that contains regulated application server (ras) software version 2. 40 as well as associated labeling and operator manual updates. The software modifications are intended to support new device models (livian), make minor software corrections, and improve ease of use with the latitude system.