Birmingham Hip Resurfacing (BHR) System
FDA premarket approval P040033/S033 · decided 2018-03-02
Approval details
- PMA number
- P040033
- Supplement
- S033
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Birmingham Hip Resurfacing (BHR) System
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2018-01-31
- Decision date
- 2018-03-02
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NXT
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- Approval for modifications to the device labeling.
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