|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||CELERITY 2D 75, 2D 85, 3D75, 3D85, PIOLOT 75,85; COROX OTW 75-UP STEROID, 85-UP, 85-BP, D75-BP|
|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 |
Replace finished steroid eluting leads with lead dummies for the particulate matter testing.