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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 NamePROSTHETIC HEART VALVE (CPHV), CARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP) AND CARBO-SEAL VALSALVA ASCENDING AORTIC PRO
Classification Nameheart-valve, mechanical
Generic Namecarbomedics prosthetic heart valve
ApplicantCARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS034
Date Received09/06/2005
Decision Date11/30/2005
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to substitute an outside vendor for specific metal components of the prosthetic heart valves. The devices, as modified, will be marketed under the trade names carbomedics prosthetic heart valve (cphv), carbo-seal ascending aortic prosthesis (aap) and carbo-seal valsalva ascending aortic prosthesis (aap).
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