BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S006 · decided 2008-11-13
Approval details
- PMA number
- P040033
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2007-04-10
- Decision date
- 2008-11-13
- Days to decision
- 583 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR A LINE EXTENSION TO THE BHR SYSTEM (IE., MODULAR VERSION OF THE BHR CUP FOR USES WITH OPTIONAL SCREWS AND APEX/SCREW HOLD COVERS) AND A SITE CHANGE (SMITH & NEPHEW, INC., MEMPHIS, TENNESSEE).
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