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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.
 
DeviceSJM BIOCOR VALVE AND SJM BIOCOR SUPRA VALVE
Generic Nameheart-valve, non-allograft tissue
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP040021
Supplement NumberS003
Date Received08/07/2006
Decision Date05/25/2007
Product Code LWR 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day 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 ADDITION OF THE 29MM BIOCOR AORTIC VALVE; ADDITION OF SIZES 25MM AND 27MM BICOR SUPRA AORTIC VALVE; A CHANGE IN THE PACKAGE SOLUTION CONCENTRATION; A REDUCED PRE-IMPLANT RINSE TIME; A CHANGE IN THE VALE HOLDER AND HOLDER HANDLE DESIGNS; AND ADDITIONAL HEMODYNAMIC DATA FOR THE 27MM BIOCOR MITRAL VALVE.
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