REFLECTION CERAMIC HIP SYSTEM
FDA premarket approval P030022/S025 · decided 2013-08-30
Approval details
- PMA number
- P030022
- Supplement
- S025
- Supplement type
- Real-Time Process
- Trade name
- REFLECTION CERAMIC HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2013-06-06
- Decision date
- 2013-08-30
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR 1) ADDITIONAL SIZES OF R3 CERAMIC LINERS; AND 2) REVISION OF THE REFLECTION CERAMIC HIP SYSTEM LABELING (SURGICAL TECHNIQUE MANUAL AND SURGEON LABELING) TO REFLECT THE ADDITIONAL COMPONENTS.
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