BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S001 · decided 2006-10-13
Approval details
- PMA number
- P040033
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2006-08-23
- Decision date
- 2006-10-13
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR: 1) ADDITION OF INTERMEDIATE SIZED FEMORAL HEAD COMPONENTS TO THE BHR SYSTEM (40MM, 44MM, 48MM, 52MM AND 56MM); 2) ADDITION OF ACETABULAR CUPS THAT MATE WITH THE INTERMEDIATE SIZED FEMORAL HEAD COMPONENTS (STANDARD, DYSPLASIA AND BRIDGING); AND 3) REVISIONS TO THE BHR LABELING TO REFLECT THE ADDITIONAL INTERMEDIATE SIZED COMPONENTS.
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