|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||EPICARDIAL PATCH LEAD|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Remove the annual requirement for ethylene oxide residual testing at medtronic final device manufacturing facilities.