ASCENSION MCP
FDA premarket approval P000057/S014 · decided 2025-08-05
Approval details
- PMA number
- P000057
- Supplement
- S014
- Supplement type
- 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
- 2025-07-09
- Decision date
- 2025-08-05
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- Approval to introduce new quarterly product endotoxin testing.
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