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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 Namevalve rotator
PMA NumberP900060
Supplement NumberS018
Date Received09/18/1998
Decision Date03/17/1999
Product Code
LWQ[ Registered Establishments with LWQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a sewing cuff modification of the carbomedics(r) prosthetic heart valve. The device, as modified, will be marketed under the trade name sulzer carbomedics orbis(tm) prosthetic heart valve and will be available in the following model numbers and sizes: model 100 (aortic sizes 19, 21, 23, 25, 27, 29, and 31mm), and model 200 (mitral sizes 21, 23, 25, 27, 29, 31, and 33mm).