PMA P050016S010
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S010
- Product code
- NXT
- Decision date
- 2014-04-03
- 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 CORMET HIP RESURFACING SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.
Current openFDA PMA Record#
- Device
- CORMET HIP RESURFACING SYSTEM
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S010
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2014-04-03
- Decision code
- APPR
- Date received
- 2013-12-13
- 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 CORMET HIP RESURFACING SYSTEM TO INCLUDE MR CONDITIONAL LANGUAGE IN THE WARNINGS AND PRECAUTIONS FOR THE SYSTEM.