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Medtronic PulseSelect™ Pulsed Field Ablation (PFA) System - HSA Registration DE0510219

Access comprehensive regulatory information for Medtronic PulseSelect™ Pulsed Field Ablation (PFA) System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510219 and owned by Medtronic, Inc. The device was registered on January 08, 2025.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0510219
Medtronic PulseSelect™ Pulsed Field Ablation (PFA) System
HSA Registration Number: DE0510219
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Product 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).

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0510219
Registration Date
January 08, 2025
Retention Due Date
January 07, 2026
Product Owner
Short Name
Medtronic, Inc
Address
710 Medtronic Parkway, Minneapolis, MN 55432, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
PulseSelect™ Pulsed Field Ablation Loop Catheter PulseSelect™ Pulsed Field Ablation Generator
Model Identifier(s)
PSCC100 PSG100