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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.
 
DeviceOMNICARBON CARDIAC VALVE PROSTHESIS
Generic NameHEART-VALVE, MECHANICAL
ApplicantMedical Cv, Inc.
9725 S. Robert Trl.
Inver Grove Heights, MN 55077
PMA NumberP830039
Supplement NumberS007
Date Received10/24/1996
Decision Date07/26/2001
Withdrawal Date09/17/2007
Product Code LWQ 
Docket Number 01M-0380
Notice Date 09/05/2001
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE OMNICARBON(TM) CARDIAC VALVE PROSTHESIS, AORTIC MODEL 3313 IN SIZES 23, 25, 27, AND 29 MM, AND MITRAL SUPRA-ANNULAR MODEL 3523 IN SIES 27, 29, 31, AND 33 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF DYSFUNCTIONING NATIVE OR PROSTHETIC AORTIC OR MITRAL HEART VALVES.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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