CERAMIC TRANSCEND HIP ARTICULATION
FDA premarket approval P030027 · decided 2003-07-07
Approval details
- PMA number
- P030027
- Trade name
- CERAMIC TRANSCEND HIP ARTICULATION
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Microport Orthopedics, Inc.
- Date received
- 2003-06-12
- Decision date
- 2003-07-07
- Days to decision
- 25 days
- Decision code
- APWD
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Arlington, TN
- 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.
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