|Trade Name||MEDTRONIC REVEAL PLUS INSERTABLE LOOP RECORDER (ILR) APPLICATION SOFTWARE MODEL 9809|
|Classification Name||pulse generator, permanent, implantable|
|Generic Name||implantable pulse generator|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a software update, software series 5. 0 to software series 6. 0, to correct a minor customer inconvenience anomaly with telemetry error conditions related to the retry strategy by addition of an enhancement check to ensure that all of the event data has been received.