REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
FDA premarket approval P030022/S032 · decided 2015-09-25
Approval details
- PMA number
- P030022
- Supplement
- S032
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2015-07-27
- Decision date
- 2015-09-25
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR AN INNER LID PACKAGING CHANGE TO BIOLOX FORTE CERAMIC HEADS.
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