PMA P000057S012
- Device
- Ascension MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S012
- Product code
- NEG
- Decision date
- 2024-03-20
- Classification
- Orthopedic
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Approval order statement
- Approval to add MR Conditional labeling
Current openFDA PMA Record#
- Device
- Ascension MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S012
- Product code
- NEG
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Decision date
- 2024-03-20
- Decision code
- APPR
- Date received
- 2024-01-05
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to add MR Conditional labeling