|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||COROX OTW (-S) BP LEFT VENTRICULAR LEADS|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval of the post-approval study protocol.