REFLECTION CERAMIC ACETABULAR HIP SYSTEM
FDA premarket approval P030022/S036 · decided 2016-07-22
Approval details
- PMA number
- P030022
- Supplement
- S036
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- REFLECTION CERAMIC ACETABULAR HIP SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2016-06-23
- Decision date
- 2016-07-22
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for a labeling change for the REFLECTION Ceramic Acetabular Hip System which also includes the R3 Ceramic Acetabular Hip System.
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