FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM
FDA premarket approval P000035/S002 · decided 2002-09-12
Approval details
- PMA number
- P000035
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM AND FOSSA-EMINENCE PROSTHESIS SYSTEM
- Generic name
- Glenoid fossa prosthesis
- Applicant
- Nexus CMF, LLC
- Date received
- 2002-06-20
- Decision date
- 2002-09-12
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- MPI
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR THE "CRYSTAL CLEAR ANATOMICAL MODEL PACKAGE INSERT."
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