R3 DELTA Ceramic Hip System
FDA premarket approval P150030/S041 · decided 2024-07-23
Approval details
- PMA number
- P150030
- Supplement
- S041
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- R3 DELTA Ceramic Hip System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2024-06-25
- Decision date
- 2024-07-23
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- a replacement of the current micrometer with a Nanovea Optical Profilometer PS50 for measuring the overall coating thickness of vacuum plasma spray (VPS) coating of test plates (TP) coated as part of the VPS implant coating process for manufacturing POLARSTEM Stems
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