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Nitron CryoConsole™

by Medtronic, Inc.

Ref NITRON

Nitron CryoConsole™ is a device classified as Class IIb in the EU and Class III in the US made by Medtronic, Inc., registered in EUDAMED on 12 May 2026 (Basic UDI-DI 0763000B00003347E), approved under FDA PMA P020045 on 17 Apr 2003 and listed in FDA GUDID since 15 Feb 2024 (UDI-DI 00763000593919), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR PMA

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

PMA P020045

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00003347E Basic UDI-DI 00763000593919UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000593919 UDI-DI Date15 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP020045 Date17 Apr 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00003347E registered 12 May 2026 Active
  • FDA PMA P020045 decided 17 Apr 2003 Active
  • FDA GUDID UDI-DI 00763000593919 listed 15 Feb 2024 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2777-2015 FDA Class II initiated 1 Sep 2015

    An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time.

    • Terminated Z-1452-06 FDA Unclassified (pre-2012) initiated 4 Aug 2006

    Outer cartons of catheters were mislabeled with two different reference numbers. The front of the package showed the correct reference number; 207F1, however the section on the top of the box incorrectly referenced 207F3. All inside labels (inside the box and affixed on device pouches) showed the correct reference number, 207F1.

Timeline

5 dated events

  1. Approved FDA PMA P020045
  2. Recall initiated FDA recalls Z-1452-06
  3. Recall initiated FDA recalls Z-2777-2015
  4. Listed FDA GUDID 00763000593919
  5. Registered EUDAMED 0763000B00003347E

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Generic name
Cardiac cryosurgical system
Device name
Cryo Console Europe configuration
Model / reference
NITRON
Primary DI / UDI-DI
00763000593919 EUDAMED
00763000593902 GUDID
Basic UDI-DI
0763000B00003347E
PMA number
FDA product code
LPB
EMDN code
Z120101 Arteriotomy ablators
GMDN term
Cardiac cryosurgical system
Device class
Class IIb EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00763000593919
GUDID
00763000593902
Device classEUDAMED
Class IIb
GUDID
Class III

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000593919; FDA GUDID lists 00763000593902), so their flags are not compared. Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cardiac cryosurgical system

Cleared under the same submission (P020045)

and 8 more cleared under P020045

Similar devices in this category

Other devices filed under GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)