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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePINNACLE COMPLETE ACETABULAR HIP SYSTEM
Classification Nameprosthesis, hip, semi-constrained, ceramic-on-metal articulation
ApplicantDEPUY ORTHOPAEDICS, INC.
PMA NumberP090002
Supplement NumberS009
Date Received03/12/2013
Decision Date08/06/2013
Product Code
OVO[ Registered Establishments with OVO ]
Advisory Committee Orthopedic
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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