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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 Road B. East
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS076
Date Received06/13/2011
Decision Date08/11/2011
Product Code LWQ 
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 CHANGES TO THE SPECIFICATION RANGE FOR THE COURSES PER INCH (CPI) AND THICKNESS OF THE PTFE FABRIC USED IN THE CONSTRUCTION OF THE PTFE SEWING CUFF USED WITH THE MASTERS SERIES VALVES, AS WELL AS APPROVAL OF TWO CHANGES INTENDED TO OFFSET THE INCREASE IN THE FORCE REQUIRED FOR VALVE ROTATION (TORQUE) ASSOCIATED WITH THE FABRIC MODIFICATION. THESE PROPOSED CHANGES ARE FOR THE INCREASE IN THE DIAMETER OF THE ROTATION SPRING AND RETAINER ID AND REDUCING THE LOWER LIMIT OF TORQUE FROM 2.0 IN-OZ TO 0.2 IN-OZ.
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