PMA P050016S012
- Device
- Cormet Hip Resurfacing System
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S012
- Product code
- NXT
- Decision date
- 2020-07-17
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Approval order statement
- Approval for an update to the device labeling (i.e., package insert) to include a summary of the results of the completed long-term post-approval study (PAS).
Current openFDA PMA Record#
- Device
- Cormet Hip Resurfacing System
- Applicant
- Corin USA
- PMA number
- P050016
- Supplement
- S012
- Product code
- NXT
- Generic name
- Prosthesis, hip, semi-constrained, metal/metal, resurfacing
- Decision date
- 2020-07-17
- Decision code
- APPR
- Date received
- 2019-01-25
- 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 (i.e., package insert) to include a summary of the results of the completed long-term post-approval study (PAS).