BIRMINGHAM HIP RESURFACING SYSTEM
FDA premarket approval P040033/S025 · decided 2014-08-12
Approval details
- PMA number
- P040033
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BIRMINGHAM HIP RESURFACING SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2014-05-14
- Decision date
- 2014-08-12
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR AN ADDITION TO THE LABELING FOR THE BIRMINGHAM HIPRESURFACING (BHR) SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.
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