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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.
 
DevicePINNACLE COMPLETE ACETABULAR HIP SYSTEM
Generic NameProsthesis, hip, semi-constrained, ceramic-on-metal articulation
ApplicantDEPUY ORTHOPAEDICS, INC.
P.O BOX 988
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988
PMA NumberP090002
Supplement NumberS001
Date Received09/07/2011
Decision Date11/04/2011
Withdrawal Date 09/05/2013
Product Code OVO 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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