FDA device listing

Symplicity G3 Renal Denervation RF Generator Cart

FDA device listing 1088029837 · Medtronic, Inc.

Key facts

Proprietary names Symplicity G3 Renal Denervation RF Generator Cart
Owner/operator Medtronic, Inc.
Owner/operator number 2112641
Product codes BZN
Device names BZN - Cart, Emergency, Cardiopulmonary (Excluding Equipment)
Device class Class I
Classification regulations (21 CFR) 868.6175
Review panels Anesthesiology
Registered establishments Medtronic Vascular
Establishment registrations 2953200
FEI numbers 3001452571
Establishment operations Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed 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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