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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCARBOMEDICS PROSTHETIC HEART VALVE (CPHV)
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
SORIN GROUP ITALIA S.R.L
via crescentino, sn
saluggia, vc 13040
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 - manufacturer/sterilizer/packager/supplier
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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