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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 (BHR) SYSTEM
Classification Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Generic Nametotal hip resurfacing prosthesis, metal-on-metal
ApplicantSMITH&NEPHEW ORTHOPAEDICS
PMA NumberP040033
Supplement NumberS008
Date Received11/17/2008
Decision Date01/12/2009
Product Code
NXT[ Registered Establishments with NXT ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of surgical instruments for use with the bhr system and revisions to the surgical technique.
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