Cardiac Ablation Percutaneous Catheter
Basic Information
- Device Name
- Cardiac Ablation Percutaneous Catheter
- Trade Name
- THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER,THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER,THERM
- PMA Number
- P030031
- Supplement Number
- S053
- 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
- February 11, 2014
- Date Received
- June 17, 2013
- Supplement Type
- Normal 180 Day Track
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE ADDITION OF FORCE SENSING TECHNOLOGY TO THE CATHETER TIP.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THERMOCOOL SMARTTOUCH CATHETER AND IS INDICATED FOR:THE BIOSENSE WEBSTER THERMOCOOL SMARTTOUCH NAVIGATION CATHETER AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING AND RECORDING) AND, WHEN USED WITH A COMPATIBLE RF GENERATOR, FOR THE TREATMENT OF:1) TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER;2) RECURRENT DRUG/DEVICE REFRACTORY SUSTAINED MONOMORPHIC VENTRICULAR TACHYCARDIA(VT) DUE TO PRIOR MYOCARDIAL INFARCTION (MI) IN ADULTS; AND3) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.THE THERMOCOOL SMARTTOUCH NAVIGATION CATHETER PROVIDES A REAL-TIME MEASUREMENT OF CONTACT FORCE BETWEEN THE CATHETER TIP AND HEART WALL, AS WELL AS LOCATION INFORMATION WHEN USED WITH CARTO 3 NAVIGATION SYSTEM.
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 |