Singapore HSA registration DE0508902
Abbott Medical TactiFlex Sensor Enabled Ablation Catheter
Singapore·CLASS D·Abbott Medical·Registered January 26, 2024Device 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 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.
Product Owner
- Name
- Abbott Medical
- 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
About this record
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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