R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products
FDA premarket approval P150030/S042 · decided 2024-08-30
Approval details
- PMA number
- P150030
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- R3 Delta Ceramic Hip System, and POLARSTEM PMA Auxiliary Products
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2024-08-05
- Decision date
- 2024-08-30
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- the introduction of an automated blending process for POLARSTEM stems manufacturing at Smith & Nephew Orthopaedics AG, Switzerland (SNOAG)
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