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Device | DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM |
Generic Name | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented |
Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46582 |
PMA Number | P070026 |
Supplement Number | S004 |
Date Received | 11/01/2011 |
Decision Date | 04/02/2013 |
Product Code |
MRA |
Docket Number | 13M-0462 |
Notice Date | 04/24/2013 |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00953719
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM. THIS DEVICE IS INDICATED FOR NONCEMENTED USE IN SKELETALLY MATURE INDIVIDUALS UNDERGOING PRIMARY TOTAL HIP REPLACEMENT SURGERY FOR REHABILITATIONOF HIPS DAMAGED AS A RESULT OF NONINFLAMMATORY DEGENERATIVE JOINT DISEASE (NIDJD) OR ANY OF ITS COMPOSITE DIAGNOSES OF OSTEOARTHRITIS, AVASCULAR NECROSIS, AND POST-TRAUMATIC ARTHRITIS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |