BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S007 · decided 2008-06-20
Approval details
- PMA number
- P040033
- Supplement
- S007
- 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
- 2007-10-17
- Decision date
- 2008-06-20
- Days to decision
- 247 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR AUTOMATION OF TWO MANUFACTURING PROCESSES UTILIZING CNC MACHINING.
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