Ascension MCP
FDA premarket approval P000057/S011 · decided 2019-03-05
Approval details
- PMA number
- P000057
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Ascension MCP
- Generic name
- Finger semi-constrained pyrolytic carbon uncemented prosthesis
- Applicant
- Smith & Nephew, Inc.
- Date received
- 2018-10-10
- Decision date
- 2019-03-05
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- Approval for labeling changes to the package insert, surgical technique, patient information brochure, and post-operative therapy brochure.
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