TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
FDA premarket approval P000035/S007 · decided 2012-06-27
Approval details
- PMA number
- P000035
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
- Generic name
- Glenoid fossa prosthesis
- Applicant
- Nexus CMF, LLC
- Date received
- 2011-08-29
- Decision date
- 2012-06-27
- Days to decision
- 303 days
- Decision code
- APPR
- Product code
- MPI
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT TMJ MEDICAL IN GOLDEN, COLORADO.
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