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Harmony™ HARMONY-25

by Medtronic, Inc.

Ref HARMONY-25

Harmony™ HARMONY-25 is a device classified as Class III (EU), Unclassified (US) made by Medtronic, Inc., registered in EUDAMED on 21 May 2026 (Basic UDI-DI 0763000B000109982) with CE/MDR certificate 2266041TD02 valid until 1 Dec 2029, approved under FDA PMA P200046 on 26 Mar 2021 and listed in FDA GUDID since 22 Apr 2021 (UDI-DI 00763000585259), 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

1 Dec 2029

CE MDR certificate

FDA recalls

2 ongoing

This device is named in the recall

Documents

1 certificate

Certifier DEKRA Certification B.V.

PMA P200046

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 Number2266041TD02 Date4 Jun 2026IssuedStatusActive expires 1 Dec 2029
United StatesGUDID listing GUDID Number00763000585259 UDI-DI Date22 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP200046 Date26 Mar 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B000109982 registered 21 May 2026 Active· +1 more in the status table
  • FDA PMA P200046 decided 26 Mar 2021 Active
  • FDA GUDID UDI-DI 00763000585259 listed 22 Apr 2021 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2266041TD02 Active Supplemented

    Technical documentation EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    4 Jun 2026
    Expires
    1 Dec 2029
    Reason
    Change approved

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-2624-2026 FDA Class I initiated 22 May 2026

    Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.

    • Ongoing Z-0927-2022 FDA Class I initiated 2 Mar 2022

    There is potential for the capsule bond to break during the procedure.

Timeline

7 dated events

  1. Approved FDA PMA P200046
  2. Listed FDA GUDID 00763000585259
  3. Recall initiated FDA recalls Z-0927-2022
  4. Registered EUDAMED 0763000B000109982
  5. Recall initiated FDA recalls Z-2624-2026
  6. Certificate issued EUDAMED 2266041TD02
  7. Certificate expires EUDAMED 2266041TD02

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

Trade name
Harmony™
Generic name
Pulmonary transcatheter heart valve bioprosthesis
Device name
Harmony Transcatheter Pulmonary Valve
Model / reference
HARMONY-25
Primary DI / UDI-DI
00763000585259 EUDAMED
00763000338992 GUDID
Basic UDI-DI
0763000B000109982
PMA number
FDA product code
NPV
EMDN code
P070301030103 Stented biological pulmonary valves for percutaneous implant - valve tissue of animal origin
GMDN term
Pulmonary transcatheter heart valve bioprosthesis
Device class
Class III EUDAMED
Unclassified GUDID
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00763000585259
GUDID
00763000338992
Device classEUDAMED
Class III
GUDID
Unclassified

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000585259; FDA GUDID lists 00763000338992), so their flags are not compared. Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Unclassified in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Pulmonary transcatheter heart valve bioprosthesis

Cleared under the same submission (P200046)

Similar devices in this category

Other devices filed under BIOLOGICAL HEART VALVES FOR PERCUTANEOUS IMPLANTATION, WITH SUPPORT.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains animal tissues or cells
  • Serial number
Other properties (20, all answered No)