|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 Name||DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM|
|Classification Name||prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented|
|Supplement Type||normal 180 day track no user fee|
|Supplement Reason|| location change: sterilizer|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the sterilization site be added at synergy health westport ltd. , in mayo, ireland.