PMA P040033S028
- Device
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S028
- Product code
- NXT
- Decision date
- 2015-08-10
- Classification
- Prosthesis, Hip, Semi-constrained, Metal/metal, Resurfacing
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING.
Current openFDA PMA Record#
- Device
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S028
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2015-08-10
- Decision code
- APPR
- Date received
- 2015-07-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DEVICE LABELING.