|
Device | NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | BIOSENSE WEBSTER, INC. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P030031 |
Supplement Number | S004 |
Date Received | 12/01/2006 |
Decision Date | 04/23/2007 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MERGING THE LABELING FOR THE TWO APPROVED INDICATIONS FOR THE NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION CATHETERS (ATRIAL FLUTTER UNDER P030031, AND VENTRICULAR TACHYCARDIA UNDER P040036) AND UPDATING THE LABELING FOR THE CELSIUS THERMOCOOL WHICH REMAINS APPROVED FOR TREATMENT OF ATRIAL FLUTTER ONLY. |