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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
1851 east deere ave.
santa ana, CA 92705
PMA NumberP990064
Supplement NumberS002
Date Received08/01/2000
Decision Date08/29/2000
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product 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.