PMA P010068S009
- Device
- NAVISTAR RMT DS CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S009
- Product code
- OAD
- Decision date
- 2007-03-21
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- 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 NAVISTAR RMT DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING (STIMULATION AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR (WITH SOFTWARE VERSION 001/033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS 18 OR OLDER. THE NAVISTAR RMT DS CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO RMT EP NAVIGATION SYSTEM. THE NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE CATHETER IS ONLY FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS). COMPATIBILITY WITH THE STEREOTAXIS CARDIODRIVE HAS NOT BEEN DETERMINED.
Current openFDA PMA Record#
- Device
- NAVISTAR RMT DS CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S009
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2007-03-21
- Decision code
- APPR
- Date received
- 2006-01-31
- 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 NAVISTAR RMT DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER AND IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING (STIMULATION AND RECORDING), AND WHEN USED WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR (WITH SOFTWARE VERSION 001/033 OR HIGHER) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS 18 OR OLDER. THE NAVISTAR RMT DS CATHETER PROVIDES LOCATION INFORMATION WHEN USED WITH THE CARTO RMT EP NAVIGATION SYSTEM. THE NAVISTAR RMT DS DIAGNOSTIC/ABLATION STEERABLE CATHETER IS ONLY FOR USE WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS). COMPATIBILITY WITH THE STEREOTAXIS CARDIODRIVE HAS NOT BEEN DETERMINED.