ATTIC DEFECT PLATE
Device Facts
| Record ID | K921433 |
|---|---|
| Device Name | ATTIC DEFECT PLATE |
| Applicant | Smith & Nephew Richards, Inc. |
| Product Code | ETC · Ear, Nose, Throat |
| Decision Date | Mar 18, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.3430 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A middle ear mold is a preformed device that is intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane. The device permits an ample air-filled cavity to be maintained in the middle ear and promotes regeneration of the mucous membrane lining of the middle ear cavity. A middle ear mold is made of materials such as polyamide, polytetrafluoroethylene, silicone elastomer, or polyethylene, but does not contain porous polyethylene.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
