TMJ FOSSA-EMINENCE PROSTHESIS(TM)
FDA premarket approval P000035 · decided 2001-02-27
Approval details
- PMA number
- P000035
- Trade name
- TMJ FOSSA-EMINENCE PROSTHESIS(TM)
- Generic name
- Glenoid fossa prosthesis
- Applicant
- Nexus CMF, LLC
- Date received
- 2000-06-20
- Decision date
- 2001-02-27
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- MPI
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Golden, CO
- Statement
- APPROVAL FOR THE TMJ FOSSA-EMINENCE PROSTHESIS(TM). THE DEVICE IS INDICATED FOR USE IN TREATMENT OF SEVERE TEMPOROMANDIBULAR JOINT DISEASE DUE TO: 1) INFLAMMATORY ARTHRITIS INVOLVING THE TEMPOROMANDIBULAR JOINT NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT, 2) RECURRENT FIBROSIS AND/OR BONY ANKYLOSIS NOT RESPONSIVE TO OTHER MODALITIES OF TREATMENT, 3) FAILED TISSUE GRAFT, 4) FAILED ALLOPLASTIC JOINT RECONSTRUCTION, 5) INTERNAL DERANGEMENT CONFIRMED TO BE PATHOLOGICAL IN ORIGIN BY BOTH CLINICAL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.