R3 delta Ceramic Acetabular System
FDA premarket approval P150030/S006 · decided 2019-02-19
Approval details
- PMA number
- P150030
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- R3 delta Ceramic Acetabular System
- Generic name
- Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2018-11-21
- Decision date
- 2019-02-19
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- MRA
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for an additional supplier for the Inner Packaging Tyvek lid.
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