HSA · registration DE0508902Abbott Medical TactiFlex Sensor Enabled Ablation Catheter
SingaporeCardiovascularClass DAbbott Medical
Official record identity
- Registration number
- DE0508902
- Model name
- 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
- A-TFSE-D; A-TFSE-DD; A-TFSE-DF; A-TFSE-F; A-TFSE-FF; A-TFSE-FJ; A-TFSE-J; A-TFSE-JJ
- Registration date
- January 26, 2024
- Source update date
- March 24, 2026
Classification
- Risk class
- Class D
Official value: CLASS D
Published parties
- Product owner
- Abbott Medical
- Registrant / registration holder
- ABBOTT MEDICAL (SINGAPORE), PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- 5050 Nathan Lane North, Plymouth, MN 55442, United States
- Registrant address
- 3 FRASER STREET, #23-28, DUO TOWER, Singapore 189352
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.