ASCENSION ORTHOPEDICS MCP
FDA premarket approval P000057/S006 · decided 2011-08-26
Approval details
- PMA number
- P000057
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ASCENSION ORTHOPEDICS MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2010-04-07
- Decision date
- 2011-08-26
- Days to decision
- 506 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- APPROVAL FOR A CHANGE TO THE COATING SUPPLIER MANUFACTURING FACILITY.
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