REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM
FDA premarket approval P030022/S016 · decided 2010-07-30
Approval details
- PMA number
- P030022
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REFLECTION CERAMIC ACETABULAR HIP (RCHS) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2010-07-07
- Decision date
- 2010-07-30
- Days to decision
- 23 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR A CHANGE TO SMITH & NEPHEW SPECIFICATION M000286 IN TERMS OF THE AVERAGE VOLUME POROSITY OF THE POROUS COATING COMPLYING WITH THE AVERAGE VOLUME POROSITY OF 30% - 70%.
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