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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.
 
DeviceOSTEONICS ABC/TRIDENT SYSTEMS
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Generic Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, NJ 07430
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/instructions/shelf life/tradename
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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