|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||MYCARELINK PATIENT MONITOR, MYCARELINK READER FRU|
|Classification Name||pulse generator, permanent, implantable|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the test equipment/test method used in the quality control inspection process of the printed circuit board assemblies used in the mycarelink patient monitor.