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FDA PMA

Implant, cochlear

PMA Number: P200021 · 2022-11-04

ApplicantOticon Medical
Decision Date2022-11-04
PMA NumberP200021
Product CodeMCM
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeEN

Device Summary

Implant, cochlear is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Medical. It received FDA 510(k) clearance on 2022-11-04. The device is classified under product code MCM. It was reviewed by the EN advisory panel.

Frequently Asked Questions

What is the Implant, cochlear?

Implant, cochlear is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is Oticon Medical.

When did Implant, cochlear receive FDA 510(k) clearance?

The clearance date for Implant, cochlear can be found in the official FDA records.

Who is the listed applicant for Implant, cochlear?

The FDA 510(k) record lists Oticon Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implant, cochlear?

The FDA product code for Implant, cochlear is MCM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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