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PulseSelect™ PSG100

by Medtronic, Inc.

Ref PSFS100, PSCIC101, PSG100, PSRC101

PulseSelect™ PSG100 is a device classified as Class I and Class IIb in the EU and Class III in the US made by Medtronic, Inc., registered in EUDAMED on 2 Oct 2025 (Basic UDI-DI 0763000B00012327C), approved under FDA PMA P230017 on 13 Dec 2023 and listed in FDA GUDID since 13 Nov 2020 (UDI-DI 00763000617790), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

PMA P230017

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 Number0763000B00012327C Basic UDI-DI Date2 Oct 2025RegisteredStatusActive
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP230017 Date13 Dec 2023DecidedStatusActive
United StatesGUDID listing GUDID Number00763000617790 UDI-DI Date13 Nov 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00012327C registered 2 Oct 2025 Active
  • FDA PMA P230017 decided 13 Dec 2023 Active
  • FDA GUDID UDI-DI 00763000617790 listed 13 Nov 2020 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 00763000617790
  2. Approved FDA PMA P230017
  3. Registered EUDAMED 0763000B00012327C

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  • Withdrawn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
PulseSelect™
Generic name
Cardiac irreversible electroporation system generator
Foot-switch, electrical
Cardiac irreversible electroporation system remote control
Electrical-only medical device connection cable, single-use
Device name
Foot Switch
Catheter Interface Cable
PulseSelect Generator
Remote Control
Model / reference
PSG100, PSFS100, PSRC101, PSCIC101
Description
GENERATOR PSG100 PULSESELECT LOANER US
FOOTSWITCH PSFS100 PFA US
REMOTE CONTROL PSRC101 PFA 25FT US
CABLE PSCIC101 CATHETER PFA US
Primary DI / UDI-DI
00763000617790 EUDAMED
00763000617608 EUDAMED
00763000617547 EUDAMED
00763000617776 EUDAMED
00763000897215 GUDID
00763000617783 GUDID
00763000617752 GUDID
00763000617592 GUDID
Basic UDI-DI
0763000B00012327C, 0763000B00012297P, 0763000B00012277K, 0763000B00012317A
PMA number
FDA product code
QZI
EMDN code
C0280, Z120101
GMDN term
Cardiac irreversible electroporation system generator
Foot-switch, electrical
Cardiac irreversible electroporation system remote control
Electrical-only medical device connection cable, single-use
Device class
Class I EUDAMED
Class IIb EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 25.0 Feet

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00763000617790
00763000617608
00763000617547
00763000617776
GUDID
00763000897215
00763000617783
00763000617752
00763000617592
Device classEUDAMED
Class I
Class IIb
GUDID
Class III

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00763000617790, 00763000617608, 00763000617547, 00763000617776; FDA GUDID lists 00763000897215, 00763000617783, 00763000617752, 00763000617592), so their flags are not compared. Device class is stated on each registry's own scale: Class I and Class IIb in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes.

Related devices

Category: Cardiac irreversible electroporation system generator

Cleared under the same submission (P230017)

and 1 more cleared under P230017

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

  • Supplied sterile NoEUDAMEDGUDIDYesEUDAMEDGUDID
  • Single use NoGUDIDYesGUDID
  • Prescription use
  • Lot / batch number NoGUDIDYesGUDID
  • Serial number YesGUDIDNoGUDID
Other properties (20, all answered No)