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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 (CPHV)
Classification Nameheart-valve, mechanical
Generic Nameheart valve
ApplicantCARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS013
Date Received02/27/1996
Decision Date08/27/1996
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternate controlled environment for cphv manufacturing operations. The alternate controlled environment will be located within your existing manufacturing facility in calgary, alberta, canada.
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