PMA P000057S013
- Device
- Ascension MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S013
- Product code
- NEG
- Decision date
- 2025-12-31
- Classification
- Orthopedic
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Approval order statement
- Approval for a change to the raw material used in the processing of the subject device
Current openFDA PMA Record#
- Device
- Ascension MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S013
- Product code
- NEG
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Decision date
- 2025-12-31
- Decision code
- APPR
- Date received
- 2024-09-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change to the raw material used in the processing of the subject device