FDA product code PGQ: Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
PGQ is the FDA product code for cochlear implant with combined electrical stimulation and acoustic amplification. It is a Class III device, reviewed by the Ear, Nose and Throat panel. Devices under PGQ reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code. FDA has posted 3 recalls for PGQ devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Device class | Class III |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for PGQ devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-10-16.
| Year | Recalls |
|---|---|
| 2018 | 3 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8628 — Cochlear implant, external controller component, replacement
- L8616 — Microphone for use with cochlear implant device, replacement
- L8617 — Transmitting coil for use with cochlear implant device, replacement
- L8615 — Headset/headpiece for use with cochlear implant device, replacement
- L8627 — Cochlear implant, external speech processor, component, replacement
Frequently asked questions
What is FDA product code PGQ?
PGQ is the FDA product code for cochlear implant with combined electrical stimulation and acoustic amplification. It is a Class III device, reviewed by the Ear, Nose and Throat panel.
What device class is PGQ?
Class III. Typical premarket route: PMA.
Have PGQ devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2018-10-16.
Next steps
- Run an FDA pathway report with predicate devices for product code PGQ
- Run a recall and safety report across every PGQ manufacturer
- Watch product code PGQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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