REFLECTION CERAMIC ACETABULAR HIP SYSTEM (RCHS)
FDA premarket approval P030022/S039 · decided 2018-03-20
Approval details
- PMA number
- P030022
- Supplement
- S039
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- 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
- 2016-09-19
- Decision date
- 2018-03-20
- Days to decision
- 547 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for the updated physician and patient labeling based on post approval study data.
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