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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.
 
DeviceHANCOCK II BIOPROSTHESIS, MODELS T505 AND T510
Generic Namereplacement Heart-valve
Regulation Number870.3925
ApplicantMedtronic, Inc.
1851 EAST DEERE AVE.
SANTA ANA, CA 92705
PMA NumberP980043
Supplement NumberS009
Date Received02/06/2006
Decision Date06/05/2006
Product Code DYE 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO: 1) THE JAR RETAINER USED FOR BOTH THE MITRAL AORTIC CONFIGURATIONS OF HANCOCK II BIOPROSTHESES; 2) THE SERIAL NUMBER TAG FOR MITRAL AND AORTIC CONFIGURATIONS OF THE HANCOCK II BIOPROSTHESES; 3) THE VALVE HOLDER FOR THE HANCKCK II MITRAL BIOPROTHESES; AND 4) THE "INSTRUCTIONS FOR USE" TO ACCOMMODATE THE CHANGES IN THE RETAINER, TAG AND MITRAL HOLDER.
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