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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 NameOSTEONICS ABC/TRIDENT SYSTEMS
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantHOWMEDICA OSTEONICS CORP.
PMA NumberP000013
Supplement NumberS005
Date Received09/09/2004
Decision Date10/22/2004
Product Code
MRA[ Registered Establishments with MRA ]
Advisory Committee Orthopedic
Supplement Typereal-time process
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expanded indications for use (inflammatory joint disease and revision hip arthroplasty) as well as revisions to the package insert and patients labeling.
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