PMA P040033S016
- Device
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S016
- Product code
- NXT
- Decision date
- 2010-10-13
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order statement
- APPROVAL FOR REVISIONS TO THE PHYSICIAN AND PATIENT LABELING.
Current openFDA PMA Record#
- Device
- BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P040033
- Supplement
- S016
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2010-10-13
- Decision code
- APPR
- Date received
- 2010-09-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISIONS TO THE PHYSICIAN AND PATIENT LABELING.