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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 CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESIS
Classification Nameheart-valve, mechanical
Generic Namecarbomedics prosthetic heart valve
ApplicantSULZER CARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS024
Date Received06/11/2002
Decision Date12/10/2002
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to combine the carbomedics prosthetic heart valve (cphv; approved on september 29, 1993 under p900060) with the sulzer vascutek gelweave valsalva vascular prosthesis (cleared on june 13, 2002 under k013022). The device, as modified, will be marketed under the trade name carbomedics carbo-seal valsalva ascending aortic prosthesis, model cp-(size), will be available in sizes 21, 23, 25, 27, 29, 31, and 33 mm, 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 the aorta combined with disease or degeneration of the aortic valve.
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