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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
ApplicantCARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS033
Date Received05/26/2005
Decision Date07/21/2006
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at the sorin biomedica cardio, s. R. L. Facility in saluggia, italy to manufacture pyrolytic carbon components for the carbomedics prosthetic heart valve, carbo-seal ascending aortic prosthesis and carbo-seal valsalva ascending aortic prosthesis devices.
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