FDA PMA

Sensor, glucose, invasive

PMA Number: P150021 · 2026-09-01

ApplicantAbbott Diabetes Care, Inc.

Decision Date2026-09-01

PMA NumberP150021

Product CodeMDS

Device ClassClass 3

Medical SpecialtyU

Advisory CommitteeCH

Device Summary

Sensor, glucose, invasive is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2026-09-01. The device is classified under product code MDS. It was reviewed by the CH advisory panel.

Frequently Asked Questions

What is the Sensor, glucose, invasive?

Sensor, glucose, invasive is a medical device that received FDA 510(k) clearance on 2026-09-01. The listed applicant is Abbott Diabetes Care, Inc..

When did Sensor, glucose, invasive receive FDA 510(k) clearance?

The clearance date for Sensor, glucose, invasive can be found in the official FDA records.

Who is the listed applicant for Sensor, glucose, invasive?

The FDA 510(k) record lists Abbott Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sensor, glucose, invasive?

The FDA product code for Sensor, glucose, invasive is MDS.

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Official Source

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