|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||CONSULTA CRT-P, SYNCRA CRT-P|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Manufacturing process change for the printed wiring board (pwb) substrates at a medtronic second tier supplier. These pwb substrates are used in the manufacture of hybrid substrates at medtronic¿s internal supplier, medtronic tempe campus (mtc), for the devices.