Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: NAVISTAR & CELSIUS THERMOCOOL CATHETERS
• Generic Name: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
• Applicant: Biosense Webster, Inc.; 31 Technology Dr., Suite 200; Irvine, CA 92618
• PMA Number: P030031
• Supplement Number: S011
• Date Received: 08/13/2008
• Decision Date: 02/06/2009
• Product Code: OAE
• Docket Number: 09M-0071
• Notice Date: 02/18/2009
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00116428
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: Yes
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE NAVISTAR THERMOCOOL CATHETER AND EZ STEER THERMOCOOL CATHETER-NAV VERSION. THESEDEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATING ANDRECORDING), AND WHEN USED WITH THE STOCKERT 70 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.3) DRUG REFRACTORY RECURRENT SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION, WHEN USED WITH COMPATIBLE THREE-DIMENSIONAL ELECTROANATOMIC MAPPING SYSTEMS.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress