|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||MEDTRONIC HALL ROTATABLE AORTIC VALVE COLLAGEN IMPREGNATED CONDUIT|
|Classification Name||heart-valve, mechanical|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to the bioburden testing and change to the sterilization test methods.