MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS
Device Facts
| Record ID | K955615 |
|---|---|
| Device Name | MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS |
| Applicant | Misten Medical Corp. |
| Product Code | ETA · Ear, Nose, Throat |
| Decision Date | Dec 22, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3495 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.
