Ascension MCP
FDA premarket approval P000057/S013 · decided 2025-12-31
Approval details
- PMA number
- P000057
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ascension MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2024-09-27
- Decision date
- 2025-12-31
- Days to decision
- 460 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- Approval for a change to the raw material used in the processing of the subject device
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