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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.
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
PMA NumberP070026
Supplement NumberS024
Date Received10/14/2014
Decision Date03/18/2015
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the for the inclusion of the summit® porocoat® femoral prosthesis, the pinnacle® 300 series, multi-hole and sector ii acetabular shells and the tamp extractor manual surgical instrument for the newly enrolled patients study arm to the post-approval study protocol.