ASCENSION MCP
FDA premarket approval P000057/S005 · decided 2009-12-04
Approval details
- PMA number
- P000057
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- ASCENSION MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2009-10-05
- Decision date
- 2009-12-04
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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