|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 - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies.