Food and Drug Administration

Orthopedic and Rehabilitation devices Panel

September 8, 2005

Briefing Information

PMA P040033 - Birmingham Hip Resurfacing (BHR) System (PDF)

Panel Recommendation Options For Premarket Approval Applications (HTM) (PDF) (Word)

Summary of Safety and Effectiveness Data (PDF)

Draft Packaging Insert (PDF)

Draft Patient Labeling (PDF)