PMA P040033S025
- Device
- BIRMINGHAM HIP RESURFACING SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S025
- Product code
- NXT
- Decision date
- 2014-08-12
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order statement
- APPROVAL FOR AN ADDITION TO THE LABELING FOR THE BIRMINGHAM HIPRESURFACING (BHR) SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.
Current openFDA PMA Record#
- Device
- BIRMINGHAM HIP RESURFACING SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S025
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2014-08-12
- Decision code
- APPR
- Date received
- 2014-05-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AN ADDITION TO THE LABELING FOR THE BIRMINGHAM HIPRESURFACING (BHR) SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.