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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 NameBIRMINGHAM HIP RESURFACING SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Generic Nametotal hip resurfacing prosthesis, metal-on-metal
ApplicantSMITH&NEPHEW ORTHOPAEDICS
PMA NumberP040033
Supplement NumberS009
Date Received11/28/2008
Decision Date12/18/2008
Product Code
NXT[ Registered Establishments with NXT ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in location of the distribution and storage facilities to a facility in memphis, tennessee.
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