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Abbott Medical TactiFlex Sensor Enabled Ablation Catheter - HSA Registration DE0508902

Access comprehensive regulatory information for Abbott Medical TactiFlex Sensor Enabled Ablation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0508902 and owned by Abbott Medical. The device was registered on January 26, 2024.

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
DE0508902
Abbott Medical TactiFlex Sensor Enabled Ablation Catheter
HSA Registration Number: DE0508902
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Product Description

The TactiFlex Ablation Catheter, Sensor Enabled is indicated for use in creating focal lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the treatment of arrhythmias. Epicardial ablation should be limited to appropriately selected patients with ventricular tachycardia.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508902
Registration Date
January 26, 2024
Change Notification Approval Date
November 12, 2024
Retention Due Date
January 25, 2026
Product Owner
Short Name
Abbott Medical
Address
5050 Nathan Lane North, Plymouth, MN 55442, UNITED STATES
Registrant
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
Address
3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model Information
Model Name(s)
TactiFlex Sensor Enabled Ablation Catheter TactiFlex Sensor Enabled Ablation Catheter TactiFlex Sensor Enabled Ablation Catheter TactiFlex Sensor Enabled Ablation Catheter TactiFlex Sensor Enabled Ablation Catheter TactiFlex Sensor Enabled Ablation Catheter TactiFlex Sensor Enabled Ablation Catheter TactiFlex Sensor Enabled Ablation Catheter
Model Identifier(s)
A-TFSE-D A-TFSE-DD A-TFSE-DF A-TFSE-F A-TFSE-FF A-TFSE-FJ A-TFSE-J A-TFSE-JJ