PMA P000057S014
- Device
- ASCENSION MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S014
- Product code
- NEG
- Decision date
- 2025-08-05
- Classification
- Orthopedic
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Approval order statement
- Approval to introduce new quarterly product endotoxin testing.
Current openFDA PMA Record#
- Device
- ASCENSION MCP
- Applicant
- Smith & Nephew, Inc.
- PMA number
- P000057
- Supplement
- S014
- Product code
- NEG
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Decision date
- 2025-08-05
- Decision code
- OK30
- Date received
- 2025-07-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to introduce new quarterly product endotoxin testing.