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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.
 
DeviceCARBOMEDICS PROSTHETIC HEART VALVE
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
SORIN GROUP ITALIA S.R.L
via crescentino, sn
saluggia, vc 13040
PMA NumberP900060
Supplement NumberS041
Date Received02/28/2011
Decision Date12/21/2011
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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