Singapore HSA registration DE0510219
Medtronic PulseSelect™ Pulsed Field Ablation (PFA) System
Singapore·CLASS D·Medtronic, Inc·Registered January 08, 2025Device 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 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).
Product Owner
- Name
- Medtronic, Inc
- 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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS D