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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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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