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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 NumberS005
Date Received08/03/2012
Decision Date09/06/2012
Withdrawal Date09/05/2013
Product Code OVO 
Advisory Committee Orthopedic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN INDEPENDENT INSPECTOR TO PERFORM VISUAL CHECK OF THE S-ROM FEMORAL STEM COMPONENT STERILE PACKAGING.
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