Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Basic Information
- Device Name
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Trade Name
- THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER
- PMA Number
- P110016
- Supplement Number
- S003
- 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
- July 30, 2013
- Date Received
- June 25, 2012
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR ADDING A MEDIGUIDE TECHNOLOGY PASSIVE SENSOR INTO THE TIP OF THE DEVICE FOR THE PURPOSES OF AIDING NAVIGATION AND CHANGING THE COOL PATH DUO UNI-DIRECTIONAL (UNI-D) HANDLE TO A COOL PATH DUO BI-DIRECTIONAL (BI-D) HANDLE. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES COOL PATH DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND SAFIRE DUO ABLATION CATHETER, MEDIGUIDE ENABLED AND ARE INDICATED FOR CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES (MAPPING, STIMULATION, AND ABLATION) FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. THE CATHETERS ARE INTENDED FOR USE WITH A COMPATIBLE EXTERNAL PUMP AND THE IBI-1500T9-CP RF GENERATOR AT A MAXIMUM OF 50 WATTS. MEDIGUIDE ENABLED ABLATION CATHETERS ARE USED WITH THE MEDIGUIDE TECHNOLOGY TO ENABLE REAL-TIME TIP POSITIONING AND NAVIGATION. THE MEDIGUIDE TECHNOLOGY IS INDICATED FOR USE AS AN ADJUNCT TO FLUOROSCOPY.
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 |