Pure Global AI
HSA · registration DE0510219

Medtronic PulseSelect™ Pulsed Field Ablation (PFA) System

SingaporeCardiovascularClass DMedtronic, Inc
Verified
Official record identity
Registration number
DE0510219
Model name
PulseSelect™ Pulsed Field Ablation Loop Catheter; PulseSelect™ Pulsed Field Ablation (PFA) Foot Switch; PulseSelect™ Pulsed Field Ablation Generator; PulseSelect™ Pulsed Field Ablation (PFA) Remote Control; PulseSelect™ Pulsed Field Ablation (PFA) Remote Control
Model identifier
PSCC100; PSFS100; PSG100; PSRC100; PSRC101
Registration date
January 08, 2025
Source update date
April 06, 2026
Classification
Risk class
Class D
Official value: CLASS D
Published category
Cardiovascular
View exact category matches →
Published parties
Product owner
Medtronic, Inc
Registrant / registration holder
MEDTRONIC INTERNATIONAL, LTD. (Singapore Branch)
Official description

The PulseSelect PFA loop catheter is indicated for use in cardiac electrophysiological mapping (stimulation and recording) and for the treatment of atrial fibrillation (paroxysmal and persistent).

Additional source fields
Product owner address
710 Medtronic Parkway, Minneapolis, MN 55432, United States
Registrant address
50 PASIR PANJANG ROAD, #04-51, MAPLETREE BUSINESS CITY, Singapore 117384
About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.