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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.
 
DeviceCARBO-SEAL ASCENDING AORTIC PROSTHESIS (AAP)
Generic NameHEART-VALVE, MECHANICAL
ApplicantCORCYM S.r.l.
Via Crescentino, sn
Saluggia 13040
PMA NumberP900060
Supplement NumberS012
Date Received02/08/1996
Decision Date03/07/1997
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A VALVED GRAFT VERSION OF THE CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARBOMEDICS(R) CARBO-SEAL(TM) ASCENDING AORTIC PROSTHESIS (AAP) AND IS INDICATED FOR USE IN OPEN HEART SURGERY FOR SIMULTANEOUS REPLACEMENT OF THE ASCENDING AORTA AND THE AORTIC VALVE IN CASES OF ANEURYSM, DISSECTION, OR OTHER DISEASE CONDITIONS OF HTE AORTA COMBINED WITH DISEASE OR DEGENERATION OF THE AORTIC VALVE. THE DEVICE IS AVAILABLE IN THE SIZES OF 21, 23, 25, 27, 29, 31, AND 33 MM.
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