PMA P040033S024
- Device
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S024
- Product code
- NXT
- Decision date
- 2015-12-11
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE DEVICE LABELING TO INCLUDE THE RESULTS OF THE COMPLETED UNITED KINGDOM (UK) POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S024
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2015-12-11
- Decision code
- APPR
- Date received
- 2013-11-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE DEVICE LABELING TO INCLUDE THE RESULTS OF THE COMPLETED UNITED KINGDOM (UK) POST-APPROVAL STUDY.