Cardiac Ablation Percutaneous Catheter
Basic Information
- Device Name
- Cardiac Ablation Percutaneous Catheter
- Trade Name
- IBI THERAPY CARDIAC ABLATION SYSTEM
- PMA Number
- P040014
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- LPB
- Generic Name
- Cardiac ablation percutaneous catheter
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 16, 2007
- Date Received
- February 12, 2007
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A NEW RF GENERATOR, WHICH INCLUDES SOFTWARE AND HARDWARE MODIFICATIONS TO THE PREVIOUSLY APPROVED RF GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERAPY ABLATION CATHETER AND IBI 1500T9 RT ABLATION GENERATOR. THE THERAPY ABLATION CATHETER IS INDICATED FOR MAPPING AND FOR USE WITH THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS FOR: INTERRUPTION OF ACCESSORY ATRIOVENTRICULAR (AV) CONDUCTION PATHWAYS ASSOCIATED WITH TACHYCARDIA; THE TREATMENT OF AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT); OR CREATION OF COMPLETE AV NODAL BLOCK IN PATIENTS WITH A DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO AN ATRIAL ARRHYTHMIA. THE IBI 1500T9 RF ABLATION GENERATOR IS INTENDED FOR USE WITH COMPATIBLE ST. JUDE MEDICAL TEMPERATURE CONTROLLED ABLATION CATHETERS FOR CREATING ENDOCARDIAL LESIONS TO TREAT CARDIAC ARRHYTHMIAS (I.E. SUPRAVENTRICULAR TACHYCARDIAS, AND ATRIAL FLUTTER). THE GENERATOR IS INTERNALLY LIMITED TO 50 WATTS WHEN USED WITH THE THERAPY ABLATION CATHETERS.
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 |
|---|---|---|---|
| LPB | Cardiac Ablation Percutaneous Catheter | FDA class 3 | Unknown |