Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Basic Information
- Device Name
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Trade Name
- IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF
- PMA Number
- P060019
- 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 16, 2007
- Date Received
- May 30, 2006
- Expedited Review
- N
- Docket Number
- 07M-0108
Advisory Committee Statement
APPROVAL FOR THE THERAPY COOL PATH ABLATION CATHETER AND IBI 1500T9 RF ABLATION GENERATOR. THE THERAPY COOL PATH ABLATION CATHETER IS INTENDED FOR USE WITH A COMPATIBLE EXTERNAL INFUSION PUMP AND THE IBI 1500T9 RADIOFREQUENCY (RF) GENERATOR AT A MAXIMUM OF 50 WATTS. THE CATHETER IS INTENDED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. 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 COOL PATH CATHETERS. A COMPATIBLE EXTERNAL INFUSION PUMP MUST BE CONNECTED WHEN USED WITH THERAPY COOL PATH 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 |
|---|---|---|---|
| OAD | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter | FDA class 3 | Unknown |