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Ampere™ H700501

by St. Jude Medical, Inc.

Part of a family of 8 devices: see the family page

Ref H700501

Ampere™ H700501 is a device classified as Class IIb in the EU and Class III in the US made by St. Jude Medical, Inc., registered in EUDAMED on 24 Aug 2026 (Basic UDI-DI 5414734ABC00226B), approved under FDA PMA P110016 on 25 Jan 2012 and listed in FDA GUDID since 5 Feb 2015 (UDI-DI 05415067005014), active as of 24 Oct 2026.

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 found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P110016

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5414734ABC00226B Basic UDI-DI 05415067005014UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05415067005014 UDI-DI Date5 Feb 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP110016 Date25 Jan 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5414734ABC00226B registered 24 Aug 2026 Active
  • FDA PMA P110016 decided 25 Jan 2012 Active
  • FDA GUDID UDI-DI 05415067005014 listed 5 Feb 2015 Listed

Timeline

3 dated events

  1. Approved FDA PMA P110016
  2. Listed FDA GUDID 05415067005014
  3. Registered EUDAMED 5414734ABC00226B

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  • Withdrawn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
Ampere™
Generic name
Foot-switch, electrical
Device name
Ampere System
Model / Ref / Catalog
H700501
Primary DI / UDI-DI
05415067005014
Basic UDI-DI
5414734ABC00226B
PMA number
FDA product code
LPB, OAD
EMDN code
Z12059011 Cardiac ablation equipment
GMDN term
Foot-switch, electrical
Device class
Class IIb EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 15 Meter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class III

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: Foot-switch, electrical

Cleared under the same submission (P110016)

and 8 more cleared under P110016

Similar devices in this category

Other devices filed under CARDIAC ABLATION EQUIPMENT.

Other devices from St. Jude Medical, Inc.

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

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)