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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.
 
Trade NameMEDTRONIC MOSAIC PORCINE BIOPROSTHESES MODEL 305 (AORTIC) AND MODEL 310 (MITRAL)
Generic Namereplacement heart valve
ApplicantTHE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
PMA NumberP990064
Supplement NumberS004
Date Received08/29/2000
Decision Date06/07/2001
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the post-approval study protocol for the medtronic mosaic porcine bioprostheses, model 305 (aortic) and model 310 (mitral).
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