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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.
 
DeviceST JUDE MEDICAL MECHANICAL HEART VALVE
Generic NameHEART-VALVE, MECHANICAL
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS060
Date Received10/23/2006
Decision Date11/21/2007
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE SUPPLIER OF THE POLYESTER YARN THAT IS USED IN THE FABRICATION OF: 1) THE KNITTED POLYESTER TUBULAR FABRIC THAT IS THE SOURCE MATERIAL FROM THE ST. JUDE MEDICAL MECHANICAL HEART VALVE SEWING CUFFS, AND 2) THE HEMASHIELD BOVINE COLLAGEN SEALED WOVEN POLYESTER VASCULAR GRAFT.
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