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PulseSelect™

FDA UDIEUDAMED

Class III (US FDA UDI)

Ref PSFS100Ref PSCIC101Ref PSG100Ref PSRC101

by Medtronic, Inc.

Identity

Trade Name
PulseSelect™ EUDAMEDFDA UDI
Generic Name
Cardiac irreversible electroporation system generator FDA UDI
Foot-switch, electrical FDA UDI
Cardiac irreversible electroporation system remote control FDA UDI
Electrical-only medical device connection cable, single-use FDA UDI
Device Name
Foot Switch EUDAMED
Catheter Interface Cable EUDAMED
PulseSelect Generator EUDAMED
Remote Control EUDAMED
GENERATOR PSG100 PULSESELECT LOANER US FDA UDI
FOOTSWITCH PSFS100 PFA US FDA UDI
REMOTE CONTROL PSRC101 PFA 25FT US FDA UDI
CABLE PSCIC101 CATHETER PFA US FDA UDI
Model / Reference
PSG100 EUDAMEDFDA UDI
PSFS100 EUDAMEDFDA UDI
PSRC101 EUDAMEDFDA UDI
PSCIC101 EUDAMEDFDA UDI
Description
GENERATOR PSG100 PULSESELECT LOANER US FDA UDI
FOOTSWITCH PSFS100 PFA US FDA UDI
REMOTE CONTROL PSRC101 PFA 25FT US FDA UDI
CABLE PSCIC101 CATHETER PFA US FDA UDI

Identifiers

Primary DI / UDI-DI
00763000617790 EUDAMED
00763000617608 EUDAMED
00763000617547 EUDAMED
00763000617776 EUDAMED
00763000897215 FDA UDI
00763000617783 FDA UDI
00763000617752 FDA UDI
00763000617592 FDA UDI
Basic UDI-DI
0763000B00012327C EUDAMED
0763000B00012297P EUDAMED
0763000B00012277K EUDAMED
0763000B00012317A EUDAMED
PMA Number
P230017 FDA UDI
FDA Product Code
QZI FDA UDI
EMDN Code
C0280 ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
Z120101 ARTERIOTOMY ABLATORS EUDAMED
GMDN Term
Cardiac irreversible electroporation system generator FDA UDI
Foot-switch, electrical FDA UDI
Cardiac irreversible electroporation system remote control FDA UDI
Electrical-only medical device connection cable, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class IIb EUDAMED
Class III FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDIEUDAMEDFDA UDI

Single Use

No

FDA UDIFDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDIFDA UDI

Serial Number

Yes

FDA UDIFDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 25.0 Feet FDA UDI

Category: Cardiac irreversible electroporation system generator

PulseSelect™ by Medtronic, Inc. — Class III — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac irreversible electroporation system generator.

Cleared under the same submission

P230017 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic, Inc.

Sources (8)

  • FDA UDI 6be8febc-2498-4c79-bc3a-a55cd3246b83 36 fields · synced Aug 3, 2026
  • FDA UDI 43177518-7624-43c5-8d5e-ca1d311f7362 36 fields · synced May 30, 2026
  • FDA UDI 90b3d627-c1c0-4c6d-84a1-de91fae77c13 37 fields · synced May 30, 2026
  • FDA UDI 795aaae9-7a5a-468b-af49-2a33f26bda0a 36 fields · synced May 30, 2026
  • EUDAMED 6272c494-d28c-42c4-bdce-ecea62cd8377 61 fields · synced Jul 9, 2026
  • EUDAMED b46c7b7d-c660-42b0-bba1-edb3d5226d5f 61 fields · synced Jul 11, 2026
  • EUDAMED 945c0340-3b37-4099-8356-c36f8b5d4b4d 61 fields · synced Jul 24, 2026
  • EUDAMED bd89143e-0a98-49c1-b151-84778fb9b13b 61 fields · synced Aug 3, 2026