Ascension MCP
FDA premarket approval P000057/S012 · decided 2024-03-20
Approval details
- PMA number
- P000057
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ascension MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2024-01-05
- Decision date
- 2024-03-20
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- Approval to add MR Conditional labeling
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