- Device
- BIRMINGHAM HIP RESURFACING SYSTEM (BHR)
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S017
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2011-10-14
- Decision code
- APPR
- Date received
- 2010-10-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF AN ALTERNATIVE SITE FOR THE POROUS COATING PROCESS FOR THE R3 ACETABULAR SHELLS.