|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 PROSTHETIC HEART VALVES (MODELS A7700 AND M7700)|
|Classification Name||heart-valve, mechanical|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Elimination of the production pulse duplication test from the manufacturing process.