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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 NumberS015
Date Received01/11/2010
Decision Date03/09/2010
Product Code
NXT[ Registered Establishments with NXT ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of surgical instruments for use with the bhr system and an update to the surgical technique to reflect the new surgical instruments.
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