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FDA PMA

Pump, infusion, insulin, to be used with invasive glucose sensor

PMA Number: P130007 · 2018-07-11

ApplicantAnimas Corp.
Decision Date2018-07-11
PMA NumberP130007
Product CodeOYC
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeCH

Device Summary

Pump, infusion, insulin, to be used with invasive glucose sensor is the device name listed in this FDA 510(k) record. The listed applicant is Animas Corp.. It received FDA 510(k) clearance on 2018-07-11. The device is classified under product code OYC. It was reviewed by the CH advisory panel.

Frequently Asked Questions

What is the Pump, infusion, insulin, to be used with invasive glucose sensor?

Pump, infusion, insulin, to be used with invasive glucose sensor is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Animas Corp..

When did Pump, infusion, insulin, to be used with invasive glucose sensor receive FDA 510(k) clearance?

The clearance date for Pump, infusion, insulin, to be used with invasive glucose sensor can be found in the official FDA records.

Who is the listed applicant for Pump, infusion, insulin, to be used with invasive glucose sensor?

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

What is the FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor?

The FDA product code for Pump, infusion, insulin, to be used with invasive glucose sensor is OYC.

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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