|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||MOSAIC PORCINE BIOPROSTHESIS|
|Applicant||MEDTRONIC HEART VALVES|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the method in which a raw material (aoa compound) is synthesized. This will result in the raw material being received in a more purified form. In addition, the quality control test performed on incoming inspection will change from the gravimetric test method to the ninhydrin test method.