• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBirmingham Hip Resurfacing (BHR) System
Generic Nameprosthesis, hip, semi-constrained, metal/metal, resurfacing
Applicant
SMITH&NEPHEW ORTHOPAEDICS
7135 goodlett farms parkway
cordova, TN 38016
PMA NumberP040033
Supplement NumberS033
Date Received01/31/2018
Decision Date03/02/2018
Product Code NXT 
Advisory Committee Orthopedic
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the device labeling.
-
-