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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 Dr.
Warsaw, IN 46581
PMA NumberP090002
Supplement NumberS009
Date Received03/12/2013
Decision Date08/06/2013
Withdrawal Date09/05/2013
Product Code OVO 
Advisory Committee Orthopedic
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 CHANGES TO THE PROCESS PARAMETERS FOR AN EXISTING PACKAGE SEALER AND ADDITION OF AN ALTERNATE PACKAGE SEALER.
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