Skip to content

Volt™ PFA Sensor Enabled™ A-VOLT-01

by St. Jude Medical, Inc.

Ref A-VOLT-01

Volt™ PFA Sensor Enabled™ A-VOLT-01 is a Class III device made by St. Jude Medical, Inc., registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 5414734ABS0044C5), approved under FDA PMA P250022 on 19 Dec 2025 and listed in FDA GUDID since 6 Jan 2026 (UDI-DI 05415067053022), active as of 7 Nov 2026.

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

CE MDR PMA

Valid until

2 Feb 2030

CE MDR certificate

FDA recalls

None found

in data synced 7 Nov 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

PMA P250022

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734ABS0044C5 Basic UDI-DI 05415067053022UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067053022 UDI-DI Date6 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP250022 Date19 Dec 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734ABS0044C5 registered 6 Jul 2026 Active
  • FDA PMA P250022 decided 19 Dec 2025 Active
  • FDA GUDID UDI-DI 05415067053022 listed 6 Jan 2026 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 815639 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    26 May 2026
    Expires
    2 Feb 2030
    Reason
    Other

Timeline

3 dated events

  1. Approved FDA PMA P250022
  2. Listed FDA GUDID 05415067053022
  3. Registered EUDAMED 5414734ABS0044C5

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  • Withdrawn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
Volt™ PFA Sensor Enabled™
Generic name
Cardiac irreversible electroporation system catheter
Device name
Volt Ablation Catheter
Model / Ref / Catalog
A-VOLT-01
Primary DI / UDI-DI
05415067053022
Basic UDI-DI
5414734ABS0044C5
PMA number
FDA product code
QZI
EMDN code
C020304 Arrhythmogenic foci pulsed field ablation catheters
GMDN term
Cardiac irreversible electroporation system catheter
Device class
Class III
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 107.0000 Centimeter
Catheter Gauge — 12.5000 French

Related devices

Cleared under the same submission (P250022)

and 8 more cleared under P250022

Similar devices in this category

Other devices filed under CARDIAC TISSUE ABLATION DEVICES.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
Other properties (20, all answered No)