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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.
 
DeviceSULZER CARBOMEDICS ORBIS PROSTHETIC HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantCorcym S.r.l.
Via Crescentino Sn
Saluggia 13040
PMA NumberP900060
Supplement NumberS018
Date Received09/18/1998
Decision Date03/17/1999
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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).
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