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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.
 
DeviceCONSERVE PLUS TOTAL RESURFACING SYSTEM
Generic NameProsthesis, hip, semi-constrained, metal/metal, resurfacing
ApplicantMicroPort Orthopedics Inc.
5677 AIRLINE RD
ARLINGTON, TN 38002
PMA NumberP030042
Supplement NumberS004
Date Received08/27/2010
Decision Date08/08/2011
Withdrawal Date 07/17/2014
Product Code NXT 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE CONSERVE PLUS A-CLASS FEMORAL COMPONENT AND THE CONSERVE PLUS THICK ACETABULAR SHELL TO BE USED AS COMPONENTS OF THE DEVICE.
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