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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.
 
DeviceR3 delta Ceramic Acetabular System
Generic NameProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantSmith & Nephew, Inc.
1450 Brooks Rd.
Memphis, TN 38116
PMA NumberP150030
Supplement NumberS005
Date Received08/22/2018
Decision Date12/07/2018
Withdrawal Date08/11/2025
Product Code MRA 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study protocol.
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