TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
FDA premarket approval P000023 · decided 2001-01-05
Approval details
- PMA number
- P000023
- Trade name
- TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES
- Generic name
- Joint, temporomandibular, implant
- Applicant
- Nexus CMF, LLC
- Date received
- 2000-06-20
- Decision date
- 2001-01-05
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- LZD
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR THE TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESIS SYSTEM. THE DEVICE IS INDICATED FOR RECONSTRUCTION OF THE TEMPOROMANDIBULAR JOINT. PATIENTS SHOULD BE CONSIDERED IF THEY HAVE ONE OR MORE OF THE FOLLOWING CONDITIONS: 1) INFLAMMATORY ARTHRITIS INVOLVING THE TEMPOROMANDIBULAR JOINT NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT 2) RECURRENT FIBROUS AND/OR BONY ANKYLOSIS NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT 3) FAILED TISSUE GRAFT 4) FAILED ALLOPLASTIC JOINT RECONSTRUCTION 5) LOSS
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