PGQ — Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification Class III
FDA product code PGQ covers "Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- PGQ
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.