R3TM delta Ceramic Acetabular System
FDA premarket approval P150030/S043 · decided 2024-09-13
Approval details
- PMA number
- P150030
- Supplement
- S043
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- R3TM delta Ceramic Acetabular System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2024-08-15
- Decision date
- 2024-09-13
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- updates to product labelling, including Instructions for Use (IFU) and packaging labels, to include additional symbols and MR safety information for the R3 DELTA CERAMIC HIP SYSTEM implants
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