Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Basic Information
- Device Name
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Trade Name
- NAVISTAR RMT DS CATHETER
- PMA Number
- P010068
- Supplement Number
- S009
- Device Class
- FDA Class 3
- Product Code
- OAD
- Generic Name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 21, 2007
- Date Received
- January 31, 2006
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | FDA class 3 | Unknown |