Birmingham Hip Resurfacing (BHR) System
FDA premarket approval P040033/S038 · decided 2024-01-19
Approval details
- PMA number
- P040033
- Supplement
- S038
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Birmingham Hip Resurfacing (BHR) System
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2023-12-20
- Decision date
- 2024-01-19
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- a change to the Catalog Item (CI) reference codes (i.e., US market only) for the BIRMINGHAM HIP RESURFACING SYSTEM femoral head and acetabular cup implants
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