TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
FDA premarket approval P000035/S008 · decided 2012-09-06
Approval details
- PMA number
- P000035
- Supplement
- S008
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TMJ FOSSA-EMINENCE PROSTHESIS SYSTEM
- Generic name
- Glenoid fossa prosthesis
- Applicant
- Nexus CMF, LLC
- Date received
- 2012-05-03
- Decision date
- 2012-09-06
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- MPI
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR CHANGES IN DEGREASING SOLVENT, CUTTING/MACHINE LUBRICANTS AND PACKAGING EQUIPMENT.
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