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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(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS
Classification Nameheart-valve, mechanical
Generic Namecarbomedics prosthetic heart valve
ApplicantSULZER CARBOMEDICS, INC.
PMA NumberP900060
Supplement NumberS021
Date Received08/07/2000
Decision Date09/05/2000
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to a larger capacity chamber used to sterilize the sulzer carbomedics carbo-seal(r) ascending aortic prosthesis. This larger capacity chamber is located at the facility identified as sulzer vascutek located in scotland.
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