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Is MiniMed Connect FDA approved or cleared?

Yes. MiniMed Connect by Medtronic MiniMed, Inc. is named in the FDA register with a 510(k) clearance, latest decision in 2015.

In the EU: no CE listing found in EUDAMED. Not every CE-marked device is registered there yet.

This product appears to be discontinued or no longer supported by its maker.

At a glance

ProductMiniMed Connect
MakerMedtronic MiniMed, Inc.
Care areaDiabetes & metabolism
What it doesConnectivity platform for MiniMed insulin pump systems
FDA510(k), latest decision 2015
Verification levelExact product named in the FDA record (checked 18 October 2026)
EU (CE)No CE listing found
Websitemedtronicdiabetes.com
StatusFDA verified
Last checked6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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