|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||CAP SURE VDD-2 LEAD, VITATRON BRILLIANT S+ VDD LEAD|
|Classification Name||pulse generator, permanent, implantable|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Transfer of component manufacturing to a different internal supplier for the two mcrd (monolithic controlled release device) components used in the cardiac lead models.