|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 vendor of the polyester yarn used in the manufacture of the mosaic porcine bioprosthesis. Also, inclusion of the pma product in the "master submission" submitted april 3, 1998 to p970031/s006 freestyle aortic bioprosthesis. The information contained in the "master submission" is directly applicable to the polyester yarn vendor change.