FDA device listing

MMT-921T MiniMed Mio,MMT-923T MiniMed Mio,MMT-925T MiniMed Mio,MMT-941T MiniMed Mio,MMT-943T MiniMed Mio,MMT-945T…

FDA device listing 1271796021 · Medtronic

Key facts

Proprietary names MMT-921T MiniMed Mio,MMT-923T MiniMed Mio,MMT-925T MiniMed Mio,MMT-941T MiniMed Mio,MMT-943T MiniMed Mio,MMT-945T MiniMed Mio,MMT-965T MiniMed Mio,MMT-975T MiniMed Mio
Owner/operator Medtronic
Owner/operator number 10094334
Premarket submissions K032854
Product codes FPA
Device names FPA - Set, Administration, Intravascular
Device class Class II
Classification regulations (21 CFR) 880.5440
Review panels General Hospital
Registered establishments MEDTRONIC MINIMED
Establishment registrations 2032227
FEI numbers 3003166194
Establishment operations Complaint File Establishment
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 1–9 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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