TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM
FDA premarket approval P000023/S006 · decided 2012-01-31
Approval details
- PMA number
- P000023
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Nexus CMF, LLC
- Date received
- 2011-05-11
- Decision date
- 2012-01-31
- Days to decision
- 265 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR LABELING CHANGES TO UPDATE THE OWNER AND COMPANY NAME, MANUFACTURING SUITE, STANDARDIZATION OF THE PRODUCT NAMES, AND ADVERSE EVENTS SECTION RELATED TO COMPLETION OF THE POST-APPROVAL STUDY.
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