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Device | CERAMIC TRANSCEND HIP ARTICULATION |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | MicroPort Orthopedics Inc. 5677 AIRLINE RD ARLINGTON, TN 38002-0000 |
PMA Number | P030027 |
Date Received | 06/12/2003 |
Decision Date | 07/07/2003 |
Product Code |
MRA |
Docket Number | 03M-0356 |
Notice Date | 08/12/2003 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
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 |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S004 S005 S006 S007 S008 S009 |