Biosense Webster ThermoCool SmartTouch™ DiagnosticAblation Deflectable Tip Catheter

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

Johnson & Johnson International (Singapore) Pte Ltd

Class:

Class D medical device

Manufactured by:

Biosense Webster, Inc

Therapeutic area:

Cardiovascular

Therapeutic indications:

The Biosense Webster THERMOCOOL® SMARTTOUCH™ Diagnostic/Ablation Deflectable Tip Catheter and related accessories are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used in conjunction with a radiofrequency generator, for cardiac ablation. The THERMOCOOL® SMARTTOUCH™ Diagnostic/Ablation Deflectable Tip Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO® 3 Navigation System.

Product summary:

Device System Info:[Sterile Medical Device], EO sterilisation; Models: ThermoCool® SmartTouch™ Bi-Directional Navigation Catheter, D-D - D132701, ThermoCool® SmartTouch™ Bi-Directional Navigation Catheter, F-F - D132702, ThermoCool® SmartTouch™ Bi-Directional Navigation Catheter, J-J - D132703, ThermoCool® SmartTouch™ Bi-Directional Navigation Catheter, F-J - D132704, ThermoCool® SmartTouch™ Bi-Directional Navigation Catheter, D-F - D132705, ThermoCool® SmartTouch™Electrophysiology Catheter, D - D133601, ThermoCool® SmartTouch™Electrophysiology Catheter, F - D133602, ThermoCool® SmartTouch™Electrophysiology Catheter, J - D133603, THERMOCOOL® SMARTTOUCH™ SF Uni-Directional Navigation Catheter, D - D134701, THERMOCOOL® SMARTTOUCH™ SF Uni-Directional Navigation Catheter, F - D134702, THERMOCOOL® SMARTTOUCH™ SF Uni-Directional Navigation Catheter, J - D134703, THERMOCOOL® SMARTTOUCH™ SF Bi-Directional Navigation Catheter, D-D - D134801, THERMOCOOL® SMARTTOUCH™ SF Bi-Directional Navigation Catheter, F-F - D134802, THERMOCOOL® SMARTTOUCH™ SF Bi-Directional Navigation Catheter, J-J - D134803, THERMOCOOL® SMARTTOUCH™ SF Bi-Directional Navigation Catheter, F-J - D134804, THERMOCOOL® SMARTTOUCH™ SF Bi-Directional Navigation Catheter, D-F - D134805

Authorization date:

2012-09-04