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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 CARBO-SEAL AND VALSALVA ASCENDING AORTIC PROSTHESIS
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
Applicant
SORIN GROUP ITALIA S.R.L
via crescentino, sn
saluggia, vc 13040
PMA NumberP900060
Supplement NumberS038
Date Received03/27/2007
Decision Date04/26/2007
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional sterilizer for sterilizing carbomedics carbo-seal and valsalva ascending aortic prosthesis devices.
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