|Trade Name||MOSAIC PORCINE BIOPROSTHESIS|
|Generic Name||replacement heart valve|
|Applicant||THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|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.