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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.
 
DeviceMOSAIC PORCINE BIOPROSTHESIS
Applicant
MEDTRONIC HEART VALVES
1851 east deere ave.
santa ana, CA 92705
PMA NumberP990064
Supplement NumberS001
Date Received07/31/2000
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 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.
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