PMA P950005S018
- Device
- CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S018
- Product code
- DRF
- Decision date
- 2005-12-16
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- APPROVAL FOR ADDING REMOTE MAGNETIC NAVIGATION TECHNOLOGY TO THE PREVIOUSLY APPROVED CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING AND FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR (4) YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.
Current openFDA PMA Record#
- Device
- CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS, MODEL D-1249-02-S
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S018
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2005-12-16
- Decision code
- APPR
- Date received
- 2004-09-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ADDING REMOTE MAGNETIC NAVIGATION TECHNOLOGY TO THE PREVIOUSLY APPROVED CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CELSIUS RMT DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING AND FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND COMPATIBLE RADIOFREQUENCY GENERATORS IN ADULTS AND CHILDREN FOUR (4) YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS.