|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|| CAPSURE LEAD, CARELINK, ENCORE AND REVEAL PROGRAMMER, MONITOR READER & SOFTWARE|
|Classification Name||pulse generator, permanent, implantable|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected medtronic cardiac rhythm disease management (crdm) products.