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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 NameCARBOMEDICS PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Namecarbomedics prosthetic heart valve
ApplicantSORIN GROUP USA INC.
PMA NumberP900060
Supplement NumberS041
Date Received04/21/2011
Decision Date12/21/2011
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the magnetic resonance imaging (mri) compatibility from 1. 5 tesla to 3. 0 tesla and to incorporate other labeling revisions for the purpose of unifying and rebranding the us market labels with other, non-us market labels.
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