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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCERAMIC TRANSCEND HIP ARTICULATION
Classification Nameprosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
ApplicantMICROPORT ORTHOPEDICS INC.
PMA NumberP030027
Date Received06/30/2003
Decision Date07/07/2003
Product Code
MRA[ Registered Establishments with MRA ]
Docket Number 03M-0356
Notice Date 08/12/2003
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the transcend hip articulation system. The device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis.
Approval Order Approval Order
Supplements: S001 S002 S004 S006 S007 
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