BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
FDA premarket approval P040033/S024 · decided 2015-12-11
Approval details
- PMA number
- P040033
- Supplement
- S024
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2013-11-21
- Decision date
- 2015-12-11
- Days to decision
- 750 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR AN UPDATE TO THE DEVICE LABELING TO INCLUDE THE RESULTS OF THE COMPLETED UNITED KINGDOM (UK) POST-APPROVAL STUDY.
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