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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
ApplicantMEDICALCV, INC.
9725 SOUTH ROBERT TRAIL
INVER GROVE HEIGHTS, MN 55077
PMA NumberP830039
Supplement NumberS011
Date Received05/07/2002
Decision Date10/29/2002
Withdrawal Date 09/17/2007
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE OMNICARBON CARDIAC VALVE PROSTHESIS IN THE ADDITIONAL SIZE OF 21 MM OF THE MODEL 3313 (AORTIC) AND SIZE 25 MM OF THE MODEL 3523 (MITRAL). THE SUPPLEMENT REQUESTED APPROVAL OF THESE SIZES AS AN ADDITION TO THE EXISTING, APPROVED (JULY 26, 2001; P830039/S007) PRODUCT LINE OF AORTIC SIZES 23, 25, 27 AND 29 MM, AND MITRAL SIZES 27, 29, 31, AND 33 MM. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC AND MITRAL VALVES.
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