ASCENSION MCP
FDA premarket approval P000057/S009 · decided 2017-08-04
Approval details
- PMA number
- P000057
- Supplement
- S009
- 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
- 2016-06-21
- Decision date
- 2017-08-04
- Days to decision
- 409 days
- Decision code
- APPR
- Product code
- NEG
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Cordova, TN
- Statement
- Approval for labeling changes to the surgical technique, patient brochure, and post-operative therapy protocol.
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