TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM
FDA premarket approval P000035/S003 · decided 2004-01-22
Approval details
- PMA number
- P000035
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMJ FOSSA EMINENCE/CONDYLAR PROSTHESIS SYSTEM
- Generic name
- Glenoid fossa prosthesis
- Applicant
- Nexus CMF, LLC
- Date received
- 2002-06-20
- Decision date
- 2004-01-22
- Days to decision
- 581 days
- Decision code
- APPR
- Product code
- MPI
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR A NEW MANUFACTURING SITE FOR THE CRYSTALCLEAR ANATOMICAL MODEL. THE SITE IS LOCATED AT TMJ IMPLANTS, INC., GOLDEN, COLORADO.
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