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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.
Classification Nameheart-valve, mechanical
Generic Nameheart-valve, mechanical
via crescentino, sn
saluggia, vc 13040
PMA NumberP900060
Supplement NumberS012
Date Received02/08/1996
Decision Date03/07/1997
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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.