BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S013 · decided 2009-12-31
Approval details
- PMA number
- P040033
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2009-07-22
- Decision date
- 2009-12-31
- Days to decision
- 162 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR A CHANGE TO NEW TESTING EQUIPMENT USED FOR MEASURING SURFACE FINISH, TAPE ANGLE, AND DIAMETER FOR THE R3 METAL LINERS.
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